Medical device recalls for June 2014

June Summary
Class I recalls: 19
Class II recalls: 240

Class I recalls

Date Posted, Recalling Manufacturer, Trade Name/Product, Reason for Recall

Jun-11-2014        Smiths Medical ASD; Inc.              Low Dead Space Connector with Sideport; 3.5mm – Portex Low Dead Space Connector with Sideport; 3.5mmProduct Usage:  The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector’s sideport permits access for administration of artificial surfactant; airway pressure monitoring; gas sampling; and instillation of sterile saline for airway leakage.                One lot of 3.0mm sized Connectors; Product Reorder No. 10035-05PS; Lot No. 2553426 were placed in packages labeled as size 3.5mm.

Jun-13-2014        Convatec Inc.     Convatec Inc. – Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.  Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition; an internal assessment of product performance; including a review of customerfeedback; has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically; the Auto-Valve feature that is unique to the Flexi-Seal Controlhas not been consistently performing relative

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating; Sterile.0.035 OD; Standard Shaft; Angled Tip; 180 CM Length;Manufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CA.Manufactured in Costa RicaThe HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.                Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating; Sterile.0.035 OD; Standard Shaft; Straight Tip; 260 CM LengthManufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CA.Manufactured in Costa RicaThe HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.                Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating; Sterile.Nitinol Guidewire with Hydrophilic Coating; Sterile.0.035 OD; Standard Shaft; Straight Tip; 180 CM Length;Manufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CA.Manufactured in Costa RicaThe HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.                Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating; Sterile.0.035 OD; Standard Shaft; Angled Tip; 260 CM Length;Manufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CA.Manufactured in Costa RicaThe HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.                Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating; Sterile.0.035 OD; Stiff Shaft; Straight Tip; 260 CM Length;Manufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CA;Manufactured in Costa RicaThe HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.               Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating; Sterile.0.035 OD; Standard Shaft; Angled Tip; 150 CM LengthManufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CA.Manufactured in Costa RicaThe HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.                Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating; Sterile.0.035 OD; Standard Shaft; Straight Tip; 150 CM LengthManufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CA.Manufactured in Costa RicaThe HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.                Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating; Sterile.0.035 OD; Stiff Shaft; Angled Tip; 150 CM Length;Manufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CAManufactured in Costa RicaThe HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.               Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating; Sterile.0.035 OD; Stiff Shaft; Angled Tip; 180 CM Length;Manufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CAManufactured in Costa Rica.The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.               Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating; Sterile.0.035 OD; Stiff Shaft; Straight Tip; 150 CM Length;Manufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CA.Manufactured in Costa RicaThe HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.               Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire;0.035 OD; Stiff Shaft; Straight Tip; 180 CM Length;Manufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CA.The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.             Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-25-2014        Nitinol Devices and Components; Inc.    HydroFinity Guidewire – HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating; Sterile.0.035 OD; Stiff Shaft; Angled Tip; 260 CM Length;Manufactured for Covidien; Plymouth; MN;Manufactured by: NDC Inc.; Fremont; CA.Manufactured in Costa RicaThe HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.               Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Jun-27-2014        Medtronic Neurosurgery             Medtronic Duet External Drainage and Monitoring System – Medtronic Duet External Drainage and Monitoring System; SmartSite Injection Sites; Catalog No. 46914.Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.           Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.

Jun-27-2014        Medtronic Neurosurgery             Medtronic Duet External Drainage and Monitoring System – Medtronic Duet External Drainage and Monitoring System; Interlink Injection Sites; Lumbar Catheter; Catalog No. 46917.Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.    Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.

Jun-27-2014        Medtronic Neurosurgery             Medtronic Duet External Drainage and Monitoring System – Medtronic Duet External Drainage and Monitoring System; SmartSite Injection Sites; Ventricular Catheter; Catalog No. 46916.Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.          Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.

Jun-27-2014        Medtronic Neurosurgery             Medtronic Duet External Drainage and Monitoring System – Medtronic Duet External Drainage and Monitoring System; Interlink Injection Sites; Ventricular Catheter; Catalog No. 46915.Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.          Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.
Jun-27-2014        Medtronic Neurosurgery             Medtronic Duet External Drainage and Monitoring System – Medtronic Duet External Drainage and Monitoring System; Interlink Injection Sites; Catalog No. 46913.Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.           Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.

Class II recalls

Date Posted, Recalling Manufacturer, Trade Name/Product, Reason for Recall

Jun-02-2014        Aesculap; Inc.    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System – Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.              AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.

Jun-02-2014        Bacterin International; Inc.          Elutia Surgical Wound Drain – Wound Drain – Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***"Two different sizes; 10 units per box:19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118.AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient’s airway or respiratory support system.      The recalling firm reported there was inadvertent omission of quarterly (Q4 – 2013 and Q1 – 2014) dose audits/verifications on the affected products.  All of the affected products were appropriately sterilized

Jun-02-2014        Integra LifeSciences Corporation              SURFIX Fixed Angle Locking Screw – Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle; foot or hand.       New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S).

Jun-02-2014        Cochlear Americas Inc.  Cochlear Baha Soft tissue gauge – Cochlear Baha Soft tissue gauge 6mm.Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm.  For use with Baha Attract hearing system.                Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient’s skin.

Jun-02-2014        Leica Microsystems; Inc.               Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi – Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438); a liquid tissue culture supernatant.   For in vitro diagnostic use.              Novocastra Liquid Mouse Monoclonal AntibodyGlutathione S-Transferase pi (Product Code: NCL-L-GSTpi-438) does not function as intended up to the expiry date on the product labeling. This was detected through an ongoing stability program. There is a linkage between the age of the product and staining intensity.

Jun-02-2014        Philips Medical Systems (Cleveland) Inc IntelliSpace Portal – IntelliSpace Portal (ISP); (ISP DX/HX/EX; Model number 881001; ISP IX; Model number 881030; ISP LX SPECT; Model number 881035); Philips Medical Systems. A medical software system for diagnostic imaging data viewing.     During SPECT reconstructions using Attenuation Correction and Scatter Correction; no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal.  In addition; resolution recovery is not applied correctly in SPECT reconstructions using Astonish in AutoSPECT Pro on Intellispace Portal.

Jun-02-2014        Ortho-Clinical Diagnostics             enGen (TM) Laboratory Automation System – enGen (TM) Laboratory Automation System configured with Data Innovations; LLC Instrument Manager (TM) (IM) v8.06 — For in vitro quantitative measurement of a variety of analytes of clinical interest —Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system; the enGen (TM) System includes one or more VITROS Chemistry; Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware); and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.              Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action; such as dilution or retesting due to a mechanical issue; it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that res

Jun-02-2014        Synthes; Inc.      Synthes XRL Medium Trial-Central Body – Synthes XRL Medium Trial – Central Body; an instrument used as part of the Synthes XRL System; a vertebral body replacement device.   For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g.; USS; including MATRIX; Pangea; and TSLP).          Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Bard Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number:  5955810Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Bard Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number:  5955460Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Bard Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number:  5955450Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – BardVentralight" ST Mesh with Echo PS" 10"x13" Reorder Number:  5955113Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Bard Ventralight" ST Mesh with Echo PS TM 7"x9"  Reorder Number:  5955790Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Bard Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number:  0144810Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Composix" LP with Echo PS" 10×13 HUXH0294HUXL0314Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Composix" LP with Echo PS" 6×8 Reorder Number:  0144680Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Bard Ventralight" ST Mesh with Echo PS" 8" Circle Number:  5955800Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Bard Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number:  0144790Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Composix" LP with Echo PS" 6×10 Reorder Number:  0144610Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Bard Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number:  5955680Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Bard Ventralight" ST Mesh with Echo PS" 12"x14"  Reorder Number:  5955124Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Bard Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number:  5955600Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-02-2014        Davol; Inc.; Subs. C. R. Bard; Inc.                Composix LP with Echo – Bard Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number:  5955610Indicated for use in the reconstruction of soft tissue deficiencies; such as the repair of hernias.                Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Jun-03-2014        GE Healthcare; LLC          Kenex Radiation Shield – Kenex Radiation Shield and surgical lamps  installed with GE Healthcare Interventional; Surgery; CT and X-Ray Imaging systems.Kenex Suspension installed with Radiation shield and lamp with following model numbers:E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC.Product Usage:Personnel protective shield is a device intended for medical purposes to protect the patient; the operator; or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.             GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is not related to the design of the Kenex product. The affected products are limited to installations completed or contracted by GE Healthcare.There has been a reported incident of a radiation shield falling from the ceil

Jun-03-2014        Hologic; Inc.        Hologic Selenia Full Field Digital Mammography System – Hologic Selenia Full Field Digital Mammography System: SEL-00002; SEL-00013; SEL-00030; SEL-00039.The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. Selenia Full Field Digital Mammography System defective relay switch; if there is a need to use the emergency off switch; the system may not turn off which could result in patient injury

Jun-03-2014        Hologic; Inc.        Hologic M-IV Mammography System – Hologic M-IV Mammography System; Model M4–00001.Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.                Selenia Full Field Digital Mammography System defective relay switch; if there is a need to use the emergency off switch; the system may not turn off which could result in patient injury

Jun-03-2014        Brainlab AG        ExacTrac – ExacTrac 5.5; an Image Processing System used for patient positioning for radiation therapy or radiosurgery.            When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS); there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient.

Jun-03-2014        C P Medical Inc.                Monoswift – Monoswift  PGCL [poly (glycolide-co-caprolactone)]  Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936.  Product is labeled sterile.  The product is sealed inside an inner foil pouch with an outside Tyvek pouch.  It is an undyed; monofilament synthetic absorbable suture with needle; size 3/0 (2.0 metric); PS-1 Needle      CP Medical; Inc.; is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength.

Jun-03-2014        LAP of America Laser Applications; LLC   CARINAsim and CARINAiso – CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.                Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso systems can encounter two safety relevant errors in the operating instructions (CARINAsim MAN-1236 Rev 2 / CARINAiso MAN-1237 Rev 2)

Jun-03-2014        Spacelabs Healthcare Inc              Ultraview SL Command Module – Spacelabs Medical Ultraview SL Command Module; Model 91496. Arrhythmia Detector and Alarm. The  Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire; monitor; and process various clinical parameters from a patient in a clinical environment.    A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.

Jun-03-2014        Hospira Inc.        Plum LifeCare 5000 – LifeCare 5000 Pump (Plum 1.6) infusion pump; indicated for  volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.           There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin; the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin; a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion

Jun-03-2014        Hospira Inc.        Plum XL – Plum XL;  Micro Macro Plum XL3 with data port; and Micro Macro Plum XL with data port infusion pumps; indicated for intravenous; arterial; short-term epidural; and parenteral administration of general I.V. fluids; medications; nutritional fluids; and blood/blood products to patients in hospital and home care environments.                There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin; the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin; a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion

Jun-03-2014        Hospira Inc.        Plum XL – Plum XL3 Multi line Infusion System; Micro Macro Plum XL3 Multi line Infusion System; and Micro Macro Plum XL Infusion System.  Infusion pumps for intravenous. arterial; short-term epidural; and parenteral administration of general I.V. fluids; medications; nutritional fluids; and blood/blood products to patients in hospital and home care environments.  There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin; the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin; a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion

Jun-04-2014        Stryker Instruments Div. of Stryker Corporation                The NAV3i Platform Power Box – The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera; SPC-3 Computer; IO-Tablet (touch screen) and the monitor).         The Stryker NAV3i Platform Power Boxes produced between December 9; 2013 and March 7; 2014 may have been assembled without electrical insulation of the soldering joints

Jun-04-2014        Siemens Medical Solutions USA; Inc        Siemens – Siemens Ysio Systems Product Usage:  The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals; clinics; and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull; chest; abdomen; and extremities and may be used on pediatric; adult and bariatric patients. It can also be used for intravenous; small interventions (like biopsy; punctures; etc.) ad emergency (trauma; critical ill) applications. Exposures may be taken with the patient sitting; standing; or in the prone position. The Ysio System is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography *CR) cassettes.  Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console; which may lead to a short circuit causing an unintended release of radiation.

Jun-04-2014        Microport Orthopedics INC.        PATH(R) THREAD CUP ADAPTOR – PATH(R) THREAD CUP ADAPTOR; REF 2007-0013; Wright Medical Technology; Inc. Orthopaedic surgical instrument.     Difficulty removing the cup adaptor from the impaction handle during surgery

Jun-04-2014        Stryker Instruments Div. of Stryker Corporation                The Stryker NAV3i Platform – The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera; SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor; articulated arms and cart housing.  This Navigation system is used in combination with surgical software for cranial; spine; ENT; orthopedic and trauma procedures.  The Stryker NAV3i Platform Power Boxes produced between December 9; 2013 and March 7; 2014 may have been assembled without electrical insulation of the soldering joints

Jun-04-2014        Siemens Medical Solutions USA; Inc        Siemens Emotion 16 and Spirit Computed Tomography Systems – Siemens SOMATOM Emotion 16 and SOMATOM Spirit Computed Tomography Systems Product Usage:  To produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.       The rubber damper may degrade and break; causing loosening of the motor mounting plates; which could lead to a series of events that could place the operator and patient at risk of injury.

Jun-04-2014        Philips Medical Systems (Cleveland) Inc Brilliance CT series; iCT; iCT SP; Ingenuity CT; Ingenuity Core; Ingenuity Core128; Ingenuity Flex; – Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series; iCT; iCT SP; Ingenuity CT; Ingenuity Core; Ingenuity Core128; Ingenuity Flex; and the MX8000 Dual v. EXP scanners)  A customer reported that the table top had become free floating.  A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.

Jun-04-2014        Medtronic Neuromodulation     Ascenda Intrathecal Catheter – Medtronic Model 8780 Ascenda Intrathecal Catheter.The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter.  Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP limits.

Jun-04-2014        Arrow International Inc Arrow Percutaneous Sheath Introducer Kits – Arrow Percutaneous Sheath Introducer KitsThe Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.   Arrow is recalling the Arrow Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vesseldamage.

Jun-04-2014        Small Bone Innovations; Inc.       SBi RingFix Olive Wires – SBi RingFix Olive WiresProduct Usage:  These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments; fixation of open and closed fractures; arthrodesis; sepsis; limb lengthening; and osteotomy. Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside.

Jun-04-2014        Toshiba American Medical Systems Inc  Toshiba Infinix Solid state x-ray imager (flat panel/digital imager) – Toshiba Infinix X-Ray Interventional System  INFX-8000V/UU.  An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.    Although the Flat Panel Detector (FPD) touch sensor is activated during use; the error message is displayed and the audible signal continues sounding during the table movement of longitudinal tilt; the movement of longitudinal tilt does not stop.

Jun-04-2014        ConMed Corporation     MACROLYTE – MACROLYTE Premie Dispersive Electrode; REF 440-2400;  CONMED CORPORATION.  The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.   ConMed Corporation has received complaints regarding sparking; no output and burning at the cord set connection.  The complaints have been confirmed by ConMed.

Jun-04-2014        Intuitive Surgical; Inc.     Assembly; Patient Side Cart – Patient Side Cart assembly; 4-arm; for use with Intuitive Surgical; Inc. da Vinci Surgical System IS 4000.  The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.         Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults; mechanical sound (e.g. scraping; squeaking; rattling); cracks or vibration in the system.

Jun-04-2014        Leica Microsystems; Inc.               NCL-L-CD15: Liquid Mouse Monoclonal Antibody CD15 – Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15); a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative.  For in vitro diagnostic use.              Product does not function as intended up to the expiry date on the product labeling.  There is a link between the age of the product and staining intensity.

Jun-04-2014        Siemens Medical Solutions USA; Inc        AXIOM Luminos dRFsystem – AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector; it can perform a range of applications including general R/F; angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. It was determined that under rare environmental conditions (i.e.; extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement of the AXIOM Luminos dRFsystem which may lead to an emergency situation and pose danger to the patients; operating personnel or to the unit.

Jun-06-2014        Maquet Medical Systems USA   PowerLED 700 Surgical Light System – Maquet PowerLED 700. Product Usage;  To provide illumination to the surgical area or the patient.            Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers).  One or several plastic fixation tabs can break; which can cause the ambient light module to partially detach.

Jun-06-2014        Alere San Diego; Inc.      Cardiac Marker Test – Alere Triage D-Dimer TestPN 98100; Lot W53884B.The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens..The Alere Triage D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.                Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured.  As a result; when testing patient sample these affected devices will either generate an error code (e.g. E4 error); or they may generate an incorrect result.

Jun-06-2014        Cenorin; LLC       HLD Systems – HLD Systems Model 610 Washer/High Level Disinfector.  Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open.Product Usage:  Usage:This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite); surfactants; and detergents) to aid in the removal of debris and visible stains. Next; the medical devices and rinsed two times with water. The final; disinfection step uses only hot water at 160 F  2 F for 30 minutes.     Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.

Jun-06-2014        Mckesson Medical Immaging     Horizon Medical Imaging – Horizon Medical ImagingHorizon Medical Imaging is a medical image and information management application that is intended to receive transmit; store; retrieve; display; print and process digital medical images; digital medical video; and associated medical information from various medical imaging systems.             Firm received a complaint that an unreported study performed that day could not be opened from the archive.

Jun-07-2014        Leica Microsystems; Inc.               Leica Ceiling Mount MSF-1 – Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes.  Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V.Intended to be used for improving the visibility of objects through magnification and illumination.       The ceiling mount supplier encountered an event in which the drive screw in the motor unit; which lifts and lowers the lower lift arm; broke. As a result; the lift arm fell down approx. 60 cm (23.6 inches).

Jun-07-2014        Leica Microsystems; Inc.               Leica Ceiling Mount MS-1F & MC-1F – Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V.Intended to be used for improving the visibility of objects through magnification and illumination.              The ceiling mount supplier encountered an event in which the drive screw in the motor unit; which lifts and lowers the lower lift arm; broke. As a result; the lift arm fell down approx. 60 cm (23.6 inches).

Jun-09-2014        Ivoclar Vivadent; Inc.      Bluephase Style Light Pin Point Probe 6>2 mm – "bluephase style Light probe Pin-point 6>2 mm black***REF # 636 241".Ultraviolet activator for polymerization for use during dental curing.          Subject of this recall is an accessory to a dental curing light called Bluephase Style. The accessory is a pin point light probe. A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.

Jun-09-2014        Beckman Coulter Inc.     Ultrasonic Transducer Kits – Ultrasonic Transducer KitsFor use with the Access Family of Immunoassay Systems*.*The Access Family of Immunoassay Systems includes the Access 2; UniCel DxI 800 and UniCel DxI 600;UniCel DxC 600i; and the UniCel DxC 880i; UniCel DxC 860i; UniCel DxC 680i; and UniCel DxC 660isystems.                Beckman Coulter is initiating a field action because   some Ultrasonic Transducer Kits werepotentially assembled with incorrect mounting screws.

Jun-09-2014        Ortho-Clinical Diagnostics             VITROS 5600 Integrated System – VITROS 5600 Integrated System; Product Code/Catalog Number 6802413 for in vitro diagnostic use.            Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS  4600 Chemistry System; the VITROS 5600  Integrated System and the VITROS  5;1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

Jun-09-2014        Ortho-Clinical Diagnostics             VITROS 4600 Chemistry System – VITROS  4600 Chemistry System; Product Code/Catalog Number 6802445   for in vitro diagnostic use.          Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS  4600 Chemistry System; the VITROS 5600  Integrated System and the VITROS  5;1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

Jun-09-2014        Ortho-Clinical Diagnostics             enGen (TM) Laboratory Automation Systems – enGen (TM) Laboratory Automation Systems (enGen) with TCAutomation (TM) — For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. — Background: The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system; the enGen (TM) System includes one or more VITROS Chemistry; Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware); and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level.  The Bypass Module is an analyzer specific module that interfaces clinical analyzers to the enGen System and allows for aspirating patient samples directly from the clinical analyzers. A sample tube carrier sensor in the Bypass Module is used to detect sample tube carriers as they leave the metering location of the Bypass.  If a tube carrier is not detected within a defined period of time (6.4 seconds) the next sample to be metered may not advance for processing.  Software anomaly: potential for delay in the reporting of patient sample test results when using enGen (TM) Laboratory Automation Systems with TCAutomation (TM) Software v2.6; v3.2 and v3.5.

Jun-09-2014        Ortho-Clinical Diagnostics             VITROS  5;1 FS Chemistry System & VITROS 5;1 FS Refurbished – VITROS  5;1 FS Chemistry System and VITROS 5;1 FS Refurbished; Product Codes/Catalog Numbers 6801375; 6801890  for in vitro diagnostic use.  Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS  4600 Chemistry System; the VITROS 5600  Integrated System and the VITROS  5;1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

Jun-09-2014        Teleflex Medical               RUSCH Easy Cath – RUSCH Easy Cath Coude Kit; 10 FR; Rx Only; Sterile; Distributed by: Teleflex Medical; Research Triangle Park; NC 27708.A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.        Product was packaged with a straight catheter rather than the correct coude (curved) catheter.

Jun-09-2014        Summit Medical; Inc.      Armstrong Grommet – Armstrong Grommet with wire Otological Ventilation TubeCatalog #:  VT-0507-01; Sterilized by Ethylene Oxide; Rx Only.Intended to provide ventilation to the middle ear space through the tympanic membrane.           One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange.  This poses no health hazard to the user or patient.

Jun-09-2014        Siemens Healthcare Diagnostics; Inc.      Siemens Healthcare Diagnostics – Siemens Healthcare Diagnostics Vista Air Compressor Siemens Healthcare Diagnostics Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting; mixing; heating; and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric; turbidimetric; chemiluminescence; nephelometric and integrated ion-selective multisensory technology for clinical use.                Siemens Healthcare Diagnostics is recalling the Vista AirCompressor replacement part: SMN 10706557 Desc: SKIT Air Compressor Assy;used on the Dimension Vista 500 and Dimension Vista 1500 systems because a smallnumber of Vista Air Compressors were miswired; which ifinstalled and powered up; could cause a fire; or becomean electrical shock hazard.

Jun-10-2014        NEO METRICS; INC.         NovaGold – Boston Scientific; NovaGold High Performance Guidewire; Rx only; Sterilized using ethylene oxide; UPN M00552010 and M00552000; Manufactured by NeoMetrics Inc; 2605 Fernbrook Lane Suite J; Plymouth; MN 55447.The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile; pancreatic; cystic; right and left hepatic ducts; and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.        Neo Metrics; Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently than anticipated. There have been no reports of illness or injury.

Jun-10-2014        Philips Medical Systems; Inc.      IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (P – IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350; 865351; 865352          IntelliVue MX40 (part numbers 865350; 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.

Jun-10-2014        Sakura Finetek USA Inc Tissue-Tek PARAFORM PROC/EMB/MEDIUM – Tissue-Tek PARAFORM PROC/EMB/MEDIUM; FORMULA 3 – 8x1Kg.         Sakura Finetek USA; Inc. is conducting a voluntary field corrective action for Tissue-TEK Paraform Processing/embedding Medium Formula3 Paraffin (Product Code 7052); Lot Number 263922 because it was identified that Lot 263922 has variations in melting temperature.

Jun-10-2014        BioDerm; Inc.     SKIN-PREP Protective Wipes – BioDerm Safe n’ Dry 21006 (Component: SKIN-PREP Protective wipes).The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external; non-invasive and nonsterile device.         On 06/08/2011; BioDerm; Inc. issued a voluntary recall of a component (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter; BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n’ Dry.  Potential bacterial contamination of Smith and Nephew skin wipes by one of their contract manufacturers.

Jun-10-2014        BioDerm; Inc.     SKIN-PREP Protective wipes – BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external; non-invasive and nonsterile device. On 06/08/2011; BioDerm; Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter; BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n’ Dry.  This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.

Jun-10-2014        Cincinnati Sub-Zero Products Inc               115 V Blanketrol II; Model 222S Hyper-Hypothermia System – 115 V Blanketrol II; Model 222S Hyper-Hypothermia System .  Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.       The incorrect voltage component was placed into the device during manufacturing. This may make the device unable to maintain patient temperature during cooling mode. The device will continue to indicate that the unit is cooling because the compressor will continue to run; however water in the reservoir will begin to return to ambient temperature. The actual water temperature will be displayed but

Jun-10-2014        BioDerm; Inc.     SKIN-PREP Protective wipes – BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external; non-invasive and nonsterile device.            On 06/08/2011; BioDerm; Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter; BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n’ Dry.  This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.

Jun-10-2014        Ortho-Clinical Diagnostics             enGen (TM) Laboratory Automation System – enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 — For in vitro quantitative measurement of a variety of analytes of clinical interest —The VITROS 5;1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest; using both VITROS Chemistry Products Slides (colorimetric endpoint; rate; ion-selective electrode; and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.). —The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system; the enGen (TM) System includes one or more VITROS Chemistry; Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware); and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. By using the enGen (TM) Laboratory Automation System as a communication interface between the LIS and the clinical analyzers in the laboratory; the user can manage the workflow to the analyzers and other devices as an integrated system. This eliminates the need for the user to program tests for each sample uniquely on each analyzer. Within the enGen (TM) Laboratory Automation System; the physical routing of samples to the correct location is also automatic. The Buffer Module functions either as a location for samples waiting for results or as a storage area for empty sample tube carriers. When a sample is presented to a clinical analyzer via the Bypass module and is metered for testing; the sample remains on the track system in the Buffer module while waiting for the test results to be generated. If all test results are generated as expected and no additional actions are required; the sample is routed to a designated Exit module where it can be removed from the track system by the user. However; there are certain situations in which a follow-up action (retest of the sample) may be necessary. In these situations; the sample is routed back to a clinical analyzer via the Bypass module to complete the follow-up action. Examples of situations requiring a retest include; but are not limited to: repeat testing when a "No Result"is generated during the initial test event; sample dilution when an out of range result is obtained during the initial test event; and routing to an alternate analyzer when the first analyzer the sample is sent to is unavailable for testing. Once the follow-up sample metering actions are complete; the sample is routed to Buffer module where it remains until testing is complete. Once all test results are obtained the sample is routed to the designated Exit module.               Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.

Jun-11-2014        Synthes; Inc.      Synthes Matrix Mandible Short Cut Plate Cutter – Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral; maxillofacial surgery.              It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.

Jun-11-2014        Philips Healthcare Inc.    Philips IntellVue Info Center – Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117  Patient Physiological Monitor.             If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason; the iX(s) will enter a reboot loop.  If one iX reboots; the issue will impact only those patients monitored on that device.  If the primary server reboots; all patients across all iX devices will be impacted.

Jun-11-2014        Cordis Corporation          Cordis EMPIRA RX PTCA Dilatation Catheter – Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S  For cardiovascular use.    Dilatation catheters could exhibit radial versus axial tears should they burst during inflation.

Jun-11-2014        CooperSurgical; Inc.        TAMPA CATHETER 5 French 33 cm. – Cooper Surgical TAMPA CATHETER 5 French 33 cm.Intended for Hysterosonography.Model Number: 61-2005   Sterility of the device may be compromised due to  unsealed pouch

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 5.0mm Barrel Bur – Stryker 5.0mm Barrel BurSterile            There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 3.0mm x 3.8mm Neuro Drill – Stryker 3.0mm x 3.8mm Neuro DrillSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.             There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch – Stryker 2.5mm x 3.6mm Neuro Drill Soft TouchSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Lindemann Drill Short; 1.6mm – Lindemann Drill Short; 1.6mmSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.             There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 5.0mm Egg Bur – Stryker 5.0mm Egg BurSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.     There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 1.3mm Wire Pass Drill – Stryker 1.3mm Wire Pass DrillSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.             There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 3.5mm Zyphr Elite Round Fluted Bur – Stryker 3.5mm Zyphr Elite Round Fluted BurSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 2.0mm Tapered Round Elite Bur – Stryker 2.0mm Tapered Round Elite BurSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.             There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch – Stryker 3.0mm x 3.8mm Neuro Drill Soft TouchSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 2.0mm Round Fluted Bur – Stryker 2.0mm Round Fluted BurSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.             There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 3.0mm Round Fluted Bur Soft Touch – Stryker 3.0mm Round Fluted Bur Soft TouchSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 5.0mm Barrel Bur – Stryker 5.0mm Barrel BurSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.     There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 3.0mm x 3.8mm Precision Neuro Drill – Stryker 3.0mm x 3.8mm Precision Neuro DrillSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 2.0mm Zyphr Elite Round Fluted Bur – Stryker 2.0mm Zyphr Elite Round Fluted BurSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 6.0mm Acorn Bur – Stryker 6.0mm Acorn BurSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.     There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 5.5mm Round Fluted Bur Soft Touch – Stryker 5.5mm Round Fluted Bur Soft TouchSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch – Stryker 4.0mm x 5.1mm Neuro Drill Soft TouchSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 1.0mm Round Fluted Bur – Stryker 1.0mm Round Fluted Bur SterileProduct Usage:The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.             There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 4.0mm Round Fluted Bur – Stryker 4.0mm Round Fluted BurSterileProduct Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.             There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 4.5mm Round Fluted Bur Aggressive – Stryker 4.5mm Round Fluted Bur AggressiveSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 5.0mm Zyphr Elite Round Fluted Bur – Stryker 5.0mm Zyphr Elite Round Fluted BurSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 6.0mm Round Fluted Bur Aggressive – Stryker 6.0mm Round Fluted Bur AggressiveSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 6.0mm Round Fluted Bur – Stryker 6.0mm Round Fluted BurSterileProduct Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.             There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive – Stryker 3.0mm x 3.8mm Neuro Drill Less AggressiveSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.              There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 6.0mm Egg Bur – Stryker 6.0mm Egg BurSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.     There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 0.5mm Round Fluted Bur – Stryker 0.5mm Round Fluted Bur SterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.             There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 5.0mm Round Fluted Bur Aggressive – Stryker 5.0mm Round Fluted Bur AggressiveSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 5.5mm Round Fluted Bur Aggressive – Stryker 5.5mm Round Fluted Bur AggressiveSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 5.0mm Acorn Bur – Stryker 5.0mm Acorn BurSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.     There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 6.0mm Zyphr Elite Round Fluted Bur – Stryker 6.0mm Zyphr Elite Round Fluted BurSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 3.0mm Round Fluted Bur Aggressive – Stryker 3.0mm Round Fluted Bur AggressiveSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.   There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-11-2014        Stryker Instruments Div. of Stryker Corporation                Stryker 1.5mm Wire Pass Drill – Stryker 1.5mm Wire Pass DrillSterileProduct Usage:  The devices are intended to be used to cut bone and bone related tissue during neurosurgery; including craniotomy and spinal surgery as well as ear; nose and throat (ENT); orthopedic; and general surgical applications including maxillofacial; craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant; Craniotomy; Vertebral Fusion and Fixation and Craniosynostosis.             There may be missing notches; partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Jun-12-2014        Teleflex Medical               Taut Operative Cholangiogram Catheter; 4.5FR (1.5mm) x 76cm – Taut Operative Cholangiogram Catheter; 4.5FR (1.5mm) x 76cmTo facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.   Several complaints were received for the metal support tube missing from the cholangiogram catheter.

Jun-13-2014        Kerr Corporation              Tytin Regular Set – Tytin Regular Set; Double Spill; 50 Capsules; Part Number 29948; Lot Number 3-1294.The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.   Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948; Lot Number 3-1294); because it may set faster than specified in the Directions for Use.

Jun-13-2014        Childrens Medical Ventures        Philips – Philips/Children’s Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.      The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up.  The presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.

Jun-14-2014        Roche Diagnostics Operations; Inc.          Roche cobas e 602 module – cobas 8000 analyzer series Operators Manual Roche cobas Filter label:  Filter (N)  Mat. No 03149773001; Contents 1; 768-320 Filter (N)Product Usage:  Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.    Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause:  consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.

Jun-14-2014        Roche Diagnostics Operations; Inc.          Modular Analytics – Roche MODULAR ANALYTICS EVO Serum Work Area (SWA); Operator’s Manual Software Version 08-02; Filter label:  Filter (N)  Mat. No 03149773001; Contents 1; 768-320 Filter (N).Product Usage:Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.              Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause:  consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.

Jun-14-2014        Roche Diagnostics Operations; Inc.          Roche cobas e 601 module – cobas 6000 analyzer series Operators Manual Roche cobas;  Filter label:  Filter (N)  Mat. No 03149773001; Contents 1; 768-320 Filter (N)Product Usage:Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.    Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause:  consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms.

Jun-16-2014        Ortho-Clinical Diagnostics             VITROS (R) Chemistry Products FS Calibrator 1 – VITROS (R) Chemistry Products FS Calibrator 1; Product Code/ Catalog Number 6801873 — For in vitro diagnostic use only — VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.   Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739); Generation (GEN) 28.

Jun-16-2014        Ortho-Clinical Diagnostics             VITROS (R) Chemistry Products Calibrator Kit 17 – VITROS (R) Chemistry Products Calibrator Kit 17; Product Code/ Catalog Number 6801701 — For in vitro diagnostic use only — VITROS Chemistry Products Calibrator Kit 17 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5;1 FS Chemistry System; the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of C-reactive protein (CRP) using VITROS hsCRP Reagent.               Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739); Generation (GEN) 28.

Jun-16-2014        Elekta; Inc.          MOSAIQ – MOSAIQ; an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.   When using CMA; if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar; the direction selection might change when the intention was only to move the mouse to a different area of the screen.

Jun-16-2014        Boston Scientific Corporation     IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) – IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Curve.The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.             Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.

Jun-16-2014        Boston Scientific Corporation     IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) – IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve.The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.                Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.

Jun-16-2014        Boston Scientific Corporation     IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) – IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve.The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.             Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.

Jun-16-2014        Boston Scientific Corporation     IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) – IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve.The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.                Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.

Jun-16-2014        Boston Scientific Corporation     IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) – IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve.The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.      Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.

Jun-16-2014        Boston Scientific Corporation     IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) – IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve.The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.      Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.

Jun-16-2014        Elekta; Inc.          Synergy XVI – Synergy XVIIntended for radiation therapy treatment.      XVI can incorrectly calculate the target position of the treatment table.

Jun-16-2014        Biomet; Inc.        EZPass Nylon Monofilament Single Pack – EZPass Nylon Monofilament Single Pack; Part number 110007379; Orthopedic Manual Surgical Instrument Sterile; single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.           The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

Jun-16-2014        Biomet; Inc.        EZPass Suture Retriever Nitinol Single Pack – EZPass Suture Retriever; Nitinol; Single Pack; Part number 10007380.  Orthopedic Manual Surgical Instrument; Sterile; single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.           The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

Jun-16-2014        Biomet; Inc.        EZPass Passer – EZPass Passer; Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.  Part numbers 904050; 904051; 904052; 904053; 904054; 904055; and 904056.       The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

Jun-17-2014        Elekta; Inc.          iGUIDE System – iGUIDE SystemProduct Usage:  The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.           A bug in the software prevents the iGUIDE software from logging off.

Jun-17-2014        GE Healthcare; LLC          Datex-Ohmeda S/5MT Compact Airway Module – GE Healthcare; Compact Airway Modules E-CO; E-COV; E-COVX; E-CAiO; E-CAiOV and E-CAiOVX.    The Datex-Ohmeda S/5MT Compact Airway Module; E-CAiOVX family is used for monitoring hospital patients respiration; ventilation; and gas exchange status.               Potential loss of airway gas measurement in the Compact Airway Gas Modules.   Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring.  If this issue occurs; the monitor will show an alarm note on monitor screen of either "Low gas sample flow" or "Check sample gas out".

Jun-17-2014        Nellcor Puritan Bennett Inc. (dba Covidien LP)    PB840 Ventilator Printed Circuit Board – Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator:  The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00.  The PB840 Ventilator System is intended to provide invasive or non-invasive ventilator support and monitoring for infant; pediatric; and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities        In the case of a loss of GUI display due to a Backlight Inverter PCBA failure; the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient.  However; there is a loss of display and thus there is a necessity to move the patient to another ventilator.

Jun-17-2014        Ebi; Llc   Cypher MIS Screw Inserter – Biomet Spine;  Cypher MIS Screw Inserter; Catalog number 14-501669; instrument for Spinal Screw Fixation System.      The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.

Jun-17-2014        RAYSEARCH LABORATORIES AB RayStation software version 4.0.3.4 – RayStation software version 4.0.3.4RayStation is a software system designed for treatment planning and analysis of radiation therapy.            This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs; including DVH; dose statistics; clinical goals and constraints or objective functions. Furthermore; if material override ROIs are used; or if the external is

Jun-17-2014        Wal Mart Stores; Inc       DVX Rage Frame Safety glasses – Safety glasses made with "Rage" frames manufactured between February 20; 2014 and February 25; 2014.    The color of the frames of the recalled glasses were either white or black.Safety Eye wear    Fifteen pairs of prescription; safety glasses did not meet required; industrial lens thickness; nor did these glasses have the OSHA-required manufacturer markings.

Jun-18-2014        Philips Medical Systems; Inc.      Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) – Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products)Product Usage:  Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.               Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.

Jun-18-2014        Philips Medical Systems; Inc.      Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) – Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products)Product Usage:  Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.               Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.

Jun-18-2014        Spacelabs Healthcare Inc              Spacelabs Healthcare Ventilator Flexport Interface – Spacelabs Healthcare Ventilator Flexport Interface; Model 90436A-07                Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport;  Model 90436A-07; where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.

Jun-18-2014        Ability Dynamics LLC       Ability Dynamics – RUSH81 Prosthetic Foot Product Usage:  Prosthetic foot for human use         Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed out in the threaded hole and this could lead to bolt failure.

Jun-19-2014        Synthes; Inc.      Synthes External Fixation Systems (Small; Medium; Large and DO) – Synthes External Fixation Systems (Small; Medium; Large and DO); bone fixation appliance components.                Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe; MR Conditional; or MR Unsafe.

Jun-19-2014        Nipro Medical Corporation          Nipro – "***NIPRO Safe Touch Safety Scalp Vein Set STERILIZED WITH ETO GAS Intended to be used for insertion into a patient’s vascular system as an indwelling device to administer fluids intravenously or to sample blood.            There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.

Jun-19-2014        Biomet; Inc.        G7 Positioning Guide Post – G7 Acetabular System Positioning Guide Post; orthopedic surgical instrument for hip prosthesis.  PN:110003500.    Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.

Jun-19-2014        Biomet; Inc.        G7 Positioning Guide Rod – G7 Acetabular System Positioning Guide Rod; orthopedic surgical instrument for hip prosthesis PN 110003458.       Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.

Jun-20-2014        SeaSpine Inc      Integra UCR 3mm Hex; Large Axial Driver. – Integra UCR 3mm Hex; Large Axial Driver.The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu"; UCR; and NewPort" Systems. The Malibu"; UCR; NewPort" Systems are intended to be used as a temporary or permanent posterior; non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. Indications For Use: The Malibu"; UCR; NewPort" Systems are intended to be used as a temporary or permanent posterior; non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of these systems. The intended use of the Malibu; UCR; and NewPort Systems; when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System; is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic; lumbar; and sacral spine.                Integra has identified through an investigation of complaints that there may be the potential for the tip of asingle lot number of the UCR 3mm Hex; Large Axial Driver; 91-1123 to twist or become rounded duringuse.

Jun-20-2014        Siemens Medical Solutions USA; Inc        Siemens LANTIS System ; LANTIS Commander; 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander – Siemens LANTIS System ; LANTIS Commander; 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 CommanderThe intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer. There is a potential risk when using LANTIS OIS System client software with operating systems for which it has not been validated and released; resulting in incorrectly stored data; such as treatment records; and LANTIS database corruption.

Jun-20-2014        Beckman Coulter Inc.     Coulter DxH Cleaner 5L – Coulter DxH Cleaner 5L; Part No. 628022.For use on UniCel DxH Systems for components that come in contact with blood samples.                Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC); automated white blood cell differential and the reticulocyte.

Jun-20-2014        Beckman Coulter Inc.     UniCel DxH 800 Coulter Cellular Analysis System – UniCel DxH 800 Coulter Cellular Analysis System; Part No. 629029; B24465; and B24802.Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.      Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC); automated white blood cell differential and the reticulocyte.

Jun-20-2014        Zimmer; Inc.       VerSys Hip System; Beaded Fullcoat Stems – VerSys Hip System; Beaded Fullcoat Stems; Zimmer; Inc.; Warsaw; IN 46581                During routine inspection; beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem; material requirements per ATS #14-04818 and ATS #14-05549; respectively.

Jun-20-2014        Beckman Coulter Inc.     Coulter DxH Cleaner 10L – Coulter DxH Cleaner 10L; Part No. 628023.For use on UniCel DxH Systems for components that come in contact with blood samples.  Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC); automated white blood cell differential and the reticulocyte.

Jun-20-2014        Beckman Coulter Inc.     UniCel DxH 600 Coulter Cellular Analysis System – UniCel DxH 600 Coulter Cellular Analysis System; Part No. B23858.Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.      Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC); automated white blood cell differential and the reticulocyte.

Jun-20-2014        BioFire Diagnostics; Inc. FilmArray Blood Culture Identification (BCID) Panel – FirmArray Blood Culture Identification (BCID) Panel; Model 2.0The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is growing in the blood culture. The following gram-positive bacteria; gram-negative bacteria; and yeast are identified using the FilmArray BCID Panel: Enterococci; Listeria monocytogenes; commonly encountered Staphylococci (including specific differentiation of Staphylococcus aureus); commonly encountered Streptococci (with specific differentiation of Streptococcus agalactiae; Streptococcus pneumoniae; and Streptococcus pyogenes); Acinetobacter baumannii; commonly encountered Enterobacteriaceae (including specific differentiation of the Enterobacter cloacae complex; Escherichia coli; Klebsiella oxytoca; Klebsiella pneumoniae; Proteus; and Serratia marcescens); Haemophilus influenzae; Neisseria meningitidis (encapsulated); Pseudomonas aeruginosa; Candida albicans; Candida glabrata; Candida krusei; Candida parapsilosis; and Candida tropicalis. The FilmArray BCID Panel also contains assays for the detection of genetic determinants of resistance to methicillin (mecA); vancomycin (vanA and vanB); and carbapenems (blaKPC) to aid in the identification of potentially antimicrobialresistant organisms in positive blood culture samples.  BioFire has identified an increased risk of false positive results when the FilmArray Blood Culture Identification (BCID) Panel is used with bioMrieux BacT/ALERT Standard Anaerobic (SN) blood culture bottles.  False positive results have been observed for Pseudomonas aeruginosa and Enterococcus.

Jun-20-2014        ConMed Corporation     ConMed ALTRUS Thermal Tissue Fusion System – Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001; 2) 10 mm x 23 cm Catalog Number: 60-9511-001; 3) 10 mm x 36 cm Catalog Number: 60-9512-001; 4) 5 mm x 16 cm Catalog Number 60-9520-001; 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36 cm Catalog Number 60-9522-001.  Products are packaged within cartons; 6 units per carton.          ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.

Jun-20-2014        Nellcor Puritan Bennett Inc. (dba Covidien LP)    Puritan Bennett 840 Ventilator – Puritan Bennett 840 Ventilator (4-840120DIUU-XX)The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant; pediatric; and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.            Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support.

Jun-21-2014        Siemens Medical Solutions USA; Inc        Siemens RAD Fluoro Uro – Siemens RAD Fluoro Uro System (Ysio; Luminos dRF; and Uroskop Omnia) with software versions VB10G. Product Usage:  Image Intensified Fluoroscopic X-ray system When using systems operating with software versions VD10A/G during a RAD examination; a malfunction can result in the image appearing very dark; which may prompt unnecessary repetition of the examination.

Jun-21-2014        VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH   ProBeat Proton Therapy System – ProBeam Proton Therapy System (HGA and HFB)Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions; tumors; and conditions anywhere in the body. where radiation treatment is indicated. Anomaly with the ProBeam System where under certain conditions; the Treatment Control and Monitoring application could fail to send treatment history records to the ARIA database.

Jun-22-2014        Baxter Corporation Englewood  Abacus 3.1 – Abacus 3.1; Pharmacy CalculatorProduct Usage:Provide pharmacy calculations for automated compounding.       Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1; when Clinimix 4.25110 is used in an order; the Nutritional Summary and any labels containing energy information may display 1;000 times less protein than is actually present in the solution.

Jun-22-2014        Philips Medical Systems (Cleveland) Inc Philips Brilliance CT Big Bore Oncology and Philips Brilliance CT Big Bore Radiology – Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System  & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product  Usage:The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. During internal testing; the Brilliance CT Big Bore was found to be out of tolerance for radio frequency emissions. Specifically; at the 48MHZ frequency; the testing indicated the Brilliance CT Big Bore was 3.5dB uV/meter higher than the applicable IEC 60601-1-2 standard specification.

Jun-23-2014        Nidek Inc             RT-5100 Refractor and RT-3100 Refractor – RT-5100 Refractor and RT-3100 Refractor;Distributed by MARCO Opthalmic:Manufactured by NIDEK CO.; Ltd.; Aichi; Japan.Instrument provides means of positioning spherical and cylindrical lenses; prisms and other optical devices in front of a subject’s eyes for purpose of determining refractive error and binocular functions.     Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.

Jun-23-2014        Teleflex Medical               RUSCH – RUSCH; LaserTube (Rubber); Laser Resistant Tracheal Tube; cuffed; Teleflex Medical; Willy-Rusch; GmbH.     A tracheal tube is a device inserted into a patient’s trachea via the nose or mouth and used to maintain an open airway.    Although the Natural Rubber Latex caution symbol is clearlydisplayed on the product label; the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the product label.

Jun-23-2014        Steris Corporation           Harmony LL 500 and Harmony LL 700 – Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems); Steris Corporation.  Model numbers YG19051 and YG19262.             Potential for the welded seam in affected monitor spring arms to crack and/or break.

Jun-23-2014        Spacelabs Healthcare Inc              Spacelabs Healthcare Qube Compact Monitor – Spacelabs Healthcare Qube Compact Monitor; Model 91390.Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces.  Spacelabs Healthcare is recalling Qube Compact Monitor; Model 91390; due to a potential chance of losing network connection after switching from hardwired Ethernet connection to using the Qube Docking Station without powering down the device. The bedside monitor and all of its alarms will continue to function normally. No one has been injured as a result of this issue.

Jun-23-2014        SteriGear; LLC    The Fig Leaf Drain Bag – SteriGear Urinary Drain Bag with Fig Leaf Cover; 2000 ml; REF 10270; The Fig Leaf; SteriGear 362 S. University Avenue; provo; UT 84601; 1-800-398-3259; SteriGear.com; Sterile; EOUrinary Drainage Collection Kit; for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter               SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.

Jun-23-2014        Western / Scott Fetzer Company              Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) – Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)              Separation events have occurred; including the VIPR separating from the Aluminum cylinder.

Jun-24-2014        LAP of America Laser Applications; LLC   PICTOR 3D – LAP LASER PICTOR 3D Multi Color Laser SystemPICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters; field and MLC contours along with a 3D patient view.     While projecting yellow lines it was notice that the yellow projection has the potential to splits into two separate red and green projections.  In this case the difference between the red and green projection was up to 2.5mm.

Jun-24-2014        NxStage Medical; Inc.    NxStage Dialysate Sack (SAK) with Concentrate – NxStage Dialysate Sack (SAK) with Concentratefor Use with PureFlow SLREF: SAK-305Lactate 45; Potassium 1; Sodium 140; Calcium 3; Magnesium 1Chloride 100; Glucose (mg/dL) 100Batch Size (liters) 40     SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Jun-24-2014        Philips Medical Systems; Inc.      Ingenia 1.5T – Ingenia 1.5T; magnetic resonance imaging system.               For some identified Ingenia systems shipped between December 2013 and March 2014; cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Jun-24-2014        Philips Medical Systems; Inc.      Ingenia 1.5T R5 – Ingenia 1.5T R5; magnetic resonance imaging system.   For some identified Ingenia systems shipped between December 2013 and March 2014; cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Jun-24-2014        Philips Medical Systems; Inc.      Ingenia 3.0T R5 – Ingenia 3.0T R5; magnetic resonance imaging system.   For some identified Ingenia systems shipped between December 2013 and March 2014; cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Jun-24-2014        NxStage Medical; Inc.    NxStage Dialysate Sack (SAK) with Concentrate – NxStage Dialysate Sack (SAK) with Concentratefor Use with PureFlow SLREF: SAK-304Lactate 45; Potassium 2; Sodium 140; Calcium 3;Magnesium 1; Chloride 101; Glucose (mg/dL) 100Batch Size (liters) 60The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.         SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Jun-24-2014        NxStage Medical; Inc.    NxStage Dialysate Sack (SAK) with Concentrate – NxStage Dialysate Sack (SAK) with Concentratefor Use with PureFlow SLREF: SAK-407Lactate 40; Potassium 1; Sodium 140; Calcium 3; Magnesium 1; Chloride 105; Glucose (mg/dL) 100Batch Size (liters) 50     SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Jun-24-2014        NxStage Medical; Inc.    "NxStage Dialysate Sack (SAK) with Concentrate – NxStage Dialysate Sack (SAK) with Concentratefor Use with PureFlow SLREF: SAK-302Lactate ; 40; Potassium 1; Sodium       140; Calcium 3;  Magnesium 1; Chloride 105; Glucose (mg/dL)   100; Batch Size (liters): 60             The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch."  SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Jun-24-2014        NxStage Medical; Inc.    NxStage Dialysate Sack (SAK) with Concentrate – NxStage Dialysate Sack (SAK) with Concentratefor Use with PureFlow SLREF: SAK-307Lactate 40; Potassium 1; Sodium 140; Calcium 3; Magnesium 1; Chloride 105; Glucose (mg/dL) 100Batch Size (liters) 50The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.         SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Jun-24-2014        NxStage Medical; Inc.    NxStage Dialysate Sack (SAK) with Concentrate – NxStage Dialysate Sack (SAK) with Concentratefor Use with PureFlow SLREF: SAK-303Lactate 45; Potassium 1; Sodium 140; Calcium 3; Magnesium 100m Chloride 100m; Glucose (mg/dL) 100Batch Size (liters) 50The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.       SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Jun-24-2014        NxStage Medical; Inc.    NxStage Dialysate Sack (SAK) with Concentrate – NxStage Dialysate Sack (SAK) with Concentratefor Use with PureFlow SLREF: SAK-306Lactate 45; Potassium 2; Sodium 140; Calcium 3; Magnesium 1; Chloride 101; Glucose (mg/dL) 100Batch Size (liters) 50The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch.         SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Jun-24-2014        Philips Medical Systems; Inc.      Ingenia 3.0T – Ingenia 3.0T; magnetic resonance imaging system.               For some identified Ingenia systems shipped between December 2013 and March 2014; cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Jun-24-2014        NxStage Medical; Inc.    "NxStage Dialysate Sack (SAK) with Concentrate – NxStage Dialysate Sack (SAK) with Concentratefor Use with PureFlow SLREF: SAK-301Lactate 45; Potassium              1; Sodium 140; Calcium 3; Magnesium 1;Chloride 100; Glucose (mg/dL) 100Batch Size (liters)     60The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch."     SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification

Jun-25-2014        The Anspach Effort; Inc.                Anspach 13 mm Drill with Depth Stop for Short Heavy Duty Attachment – ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only***This device is intended to be used with Anspach Systems        The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. When you want to protect your garden, get yourself an array of wood fencing by Long Fence.

Jun-25-2014        The Anspach Effort; Inc.                Anspach eMax Hand Control – ANSPACH***REF 98-0001***eMax Hand Control***Rx Only***This device is intended to be used with Anspach Systems               The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Arthroscopic Suture Anchor Assembly with Suture Threader – ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only***This device is intended to be used with Anspach Systems        The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom Device Speed Reducer with Bumper – ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only***This device is intended to be used with Anspach Systems               The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Sagittal MicroSaw Attachment – ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only***This device is intended to be used with Anspach Systems                The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 4 mm Fluted Ball for MRI – ANSPACH***REF SP-3014-00***4mm Fluted Ball  for MRI***Rx Only***This device is intended to be used with Anspach Systems       The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Shoulder Implant 11 mm Rod; 20 cm Long; Custom – ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod; 20cm Long; Custom***Rx Only***This device is intended to be used with Anspach Systems The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom Device eMax2 Plus Hand Control – ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only***This device is intended to be used with Anspach Systems                The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 8 mm Coarse Headless Screw with Driver – ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only***This device is intended to be used with Anspach Systems                The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom MCA5-1SD with Extended Exposure – ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only***This device is intended to be used with Anspach Systems               The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Adjustable 25 cm Mia Attachment – ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment; Custom***Rx Only***This device is intended to be used with Anspach Systems                The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Nose Cone Cover – ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only***This device is intended to be used with Anspach Systems  The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom Autolube Food Guard – ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only***This device is intended to be used with Anspach Systems                The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom eMax 2 Plus Motor with MicroMax Disconnect Sleeve – ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only***This device is intended to be used with Anspach Systems        The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 8 mm Coarse Threaded Headless Bone Screw – ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only***This device is intended to be used with Anspach Systems               The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 1.85 mm x 16 mm Fluted Router for MRI – ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only***This device is intended to be used with Anspach Systems   The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom Device Autolube III modified with a swivel – ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only***This device is intended to be used with Anspach Systems The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach eMax 2 Modified Hand Control – ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only***This device is intended to be used with Anspach Systems              The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom 5 cm Extension Sleeve – ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only***This device is intended to be used with Anspach Systems                The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 3 mm Coarse Diamond Ball for Adjustable 25 cm Mia Attachment – ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only***This device is intended to be used with Anspach Systems    The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach eMax2 Lower Profile Foot Pedal – ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only***This device is intended to be used with Anspach Systems          The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom Device SC2102 with fast stop firmware – ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only***This device is intended to be used with Anspach Systems               The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Modified Arthroscopic Knotless Suture Anchor – ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only***This device is intended to be used with Anspach Systems        The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom XMax Motor; Pneumatic – ANSPACH***Custom XMax Motor; Pneumatic***Rx Only***This device is intended to be used with Anspach Systems         The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach XMax Motor with Custom Hose – ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only***This device is intended to be used with Anspach Systems             The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom Medium Attachment with 5 mm Extended Tapered Tip – ANSPACH***REF 98-0031***Custom Medium Attachment; with 5 mm Extended Tapered Tip***Rx Only***This device is intended to be used with Anspach Systems        The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 1 mm Coarse Diamond Ball for Adjustable 25 cm Mia Attachment – ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only***This device is intended to be used with Anspach Systems    The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach MA Attachment; Straight Version – ANSPACH***MA Attachment; Straight version Custom***Rx Only***This device is intended to be used with Anspach Systems             The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 2 mm Coarse Diamond Ball for Adjustable 25 cm Mia Attachment – ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only***This device is intended to be used with Anspach Systems    The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom Circular ePlus-FP – ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only***This device is intended to be used with Anspach Systems          The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 2.37 mm Spiral Drill; for Short Attachment – ANSPACH***REF 98-0010***2.37mm Spiral Drill; for Short Attachment  (Non-Sterile)***Rx Only***This device is intended to be used with Anspach Systems             The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 3 mm Fluted Ball for Adjustable 25 cm Mia Attachment – ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only***This device is intended to be used with Anspach Systems        The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom XMax Motor; Pneumatic with Hand Control and Custom Autolube III – ANSPACH***REF 98-0034***Custom XMax Motor; Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only***This device is intended to be used with Anspach Systems                The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach eMax2 Console with Irrigation – ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only***This device is intended to be used with Anspach Systems                The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 7 cm Medium Attachment – ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only***This device is intended to be used with Anspach Systems  The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Modified QD11 Attachment with Soft Tissue Protector – ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only***This device is intended to be used with Anspach Systems             The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Arthroscopic Knotless Suture Anchor – ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only***This device is intended to be used with Anspach Systems              The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom MDA Tube for use with MA-D20 Attachment – ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only***This device is intended to be used with Anspach Systems The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Modified MDA Tube with MA-D20 Attachment – ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only***This device is intended to be used with Anspach Systems               The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 5 mm Coarse Diamond Ball – ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball; 11.5 OAL***Rx Only***This device is intended to be used with Anspach Systems                The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach 20 Degree Angle Driver – ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) – Custom***Rx Only***This device is intended to be used with Anspach Systems             The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Threaders; Arthroscopic Suture Anchor – ANSPACH***REF SP-5000-00***Threaders; Arthroscopic Suture Anchor***Rx Only***This device is intended to be used with Anspach Systems                The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Custom QD11 Attachment with thinner nose tube – ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only***This device is intended to be used with Anspach Systems             The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach XMax Motor with Custom Hose – ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only***This device is intended to be used with Anspach Systems        The Anspach Effort; Inc.  in Palm Beach Gardens; FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Jun-25-2014        The Anspach Effort; Inc.                Anspach Knotless Suture Anchor Deployment Tool; Custom – ANSPACH***Knotless Suture Anchor Deployment Tool; Custom***Rx  Only***This device is intended to be used with Anspach Systems             The Anspach Effort; Inc. in Palm Beach Gardens; FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.

Jun-25-2014        Stryker Endoscopy          Shaver Handpiece Sterilization Tray – Shaver Handpiece Sterilization Tray. Model number 272-700-000.  For sterilization of Stryker Endoscopy arthroscopic shaver.              STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.

Jun-25-2014        JAS Diagnostics Inc.         JAS Diagnostics Inc.; SDI Biomed; Drew Scientific; and ETron Diagnostics – Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.        JAS Diagnostics; Inc. of Miami Lakes; FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.

Jun-25-2014        Intuitive Surgical; Inc.     IS4000 da Vinci Xi – Endoscope accessory – IS4000 da Vinci Xi – Endoscope accessory;0 Degree; 8mm Endoscope.   Intuitive Surgical Inc.               In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System; the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue

Jun-25-2014        Intuitive Surgical; Inc.     IS4000 da Vinci Xi – Endoscope accessory – IS4000 da Vinci Xi – Endoscope accessory;30 Degree; 8mm Endoscope.  Intuitive Surgical Inc.     In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System; the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue

Jun-25-2014        Elekta; Inc.          MOSAIQ – MOSAIQMOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used where ever radiotherapy and/or chemotherapy are prescribed.               MOSAIQ does not re-calculate the agent volume when the user changes the ordering dose (to other than what was calculated) prior to saving the order.

Jun-25-2014        Integra LifeSciences Corp.            Accell Evo3c Demineralized Bone Matrix Putty – Accell Evo3C Demineralized Bone Matrix; 5 cc; Model Number:      02-6000-050 ; Lot Number: 132160.    Product Usage:Accell Evo3c Demineralized Bone Matrix Putty is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the spine; extremities and pelvis; or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.            This lot (132160) of Accell Evo3C Demineralized Bone Matrix; 5cc was incorrectly packaged in boxes that describe the product as Accell Evo3 Demineralized Bone Matrix.

Jun-25-2014        Siemens Healthcare Diagnostics; Inc.      Siemens StreamLAB(R) Analytical Workcell – Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901.Designed to automate sample handling and processing in the clinical laboratory.          Firm has received reports from customers that the small pins at the bottom of the center door panel of the Input/Output Module; which protrude approximately 5/8 inch (16 mm); have contributed to trip and fall incidents. Customers are advised that when working in the area of the Input/Output Module to be aware of the two pins that protrude and use caution.

Jun-26-2014        Biomet; Inc.        DISCOVERY ELBOW – DISCOVERY ELBOW prosthesis; 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY.                  Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.         Surface finish is different than specified.  The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast.  The patient may experience pain requiring surgical intervention.

Jun-26-2014        Siemens Healthcare Diagnostics; Inc.      Siemens Dimension TNI CAL – Siemens Dimension LOCI TNI Troponin I Calibrator  RC 621.   The LOCI TNI Troponin I Calibrator is an in vitro diagnostic product for the calibration of the cardiac troponin I (TNI) method for the Dimension clinical EXL integrated chemistry system with LOCI module.   Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.

Jun-26-2014        Zynex Medical; Inc.         IF 8000 – IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy; rehabilitation; and pain relief applications.       Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate; and in some instances;overheating and becoming hot to the touch.

Jun-26-2014        Siemens Healthcare Diagnostics; Inc        Siemens Healthcare – Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles; lot number: 454778Kit Catalog Number: 112219SMN: 10310026Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments       Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles

Jun-27-2014        Meridian Bioscience Inc                illumipro-10 Incubator/Reader – illumipro-10 Incubator/Reader; Meridian Bioscience; Inc.The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.              Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.

Jun-27-2014        Zimmer Manufacturing B.V.        NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component; Precoat – ***LOT***NexGen Complete Knee Solution***MIS Total Knee Procedure***Stemmed***Tibial Component***Precoat***Fixed Bearing***Size*** NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained; non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; Collagen disorders; and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy; Moderate valgus; varus; or flexion deformities; and the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. These devices are intended for cemented use only.      Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Jun-27-2014        Blue Belt Technologies MN          Stride Femoral Component – Stride Femoral Component Size 2; PFSI-00054; Right Medial /Left Lateral. Product Usage:  The STRIDE Unicondylar Knee devices are indicated for patients with: – Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. – Previous tibial condyle or plateau fractures with loss of anatomy or function. – Varus or valgus deformities. – Revision of previous arthroplasty procedures. These devices are indicated for cemented use only.The STRIDE Unicondylar Knee device is a unicompartmental prosthetic implant that resurfaces one femoral condyle; and one side of the tibial plateau.  The femoral component is made of cobalt chrome and the tibial component is made of titanium with a UHMWPE insert that snaps into place.  The device is non constrained; the articulating surface of the UHMWPE insert is flat and joint stability is maintained by ligaments and other soft tissue surrounding the knee.   The Stride Size 2 Femoral Implant; catalogue numbers PFSI-00053 Right Lateral/Left Medial and PFSI-00054; Right Medial/Left lateral are mislabeled.  Packages labeled PFSI-00053; Right Lateral/Left Medial contains PFSI-00054; Right Media/Left lateral implants.  Packages labeled PFSI-00054; Stride Right Media/Left Lateral contain PFSI-00053; Left Medial/Right Lateral.

Jun-27-2014        Zimmer Manufacturing B.V.        NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component; Precoat – ***LOT***NexGen Complete Knee Solution***MIS Total Knee Procedure***Stemmed***Tibial Component***Precoat***Fixed Bearing***Size*** NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained; non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; Collagen disorders; and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy; Moderate valgus; varus; or flexion deformities; and the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. These devices are intended for cemented use only.      Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Jun-27-2014        Zimmer Manufacturing B.V.        NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component; Precoat – ***LOT***NexGen Complete Knee Solution***MIS Total Knee Procedure***Stemmed***Tibial Component***Precoat***Fixed Bearing***Size*** NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained; non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; Collagen disorders; and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy; Moderate valgus; varus; or flexion deformities; and the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. These devices are intended for cemented use only.      Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Jun-27-2014        Blue Belt Technologies MN          Stride Femoral Component – Stride Femoral Component Size 2; PFSI-00053; Right  Lateral /Left Medial.  Product Usage:  The STRIDE Unicondylar Knee devices are indicated for patients with: – Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. – Previous tibial condyle or plateau fractures with loss of anatomy or function. – Varus or valgus deformities. – Revision of previous arthroplasty procedures. These devices are indicated for cemented use only.The STRIDE Unicondylar Knee device is a unicompartmental prosthetic implant that resurfaces one femoral condyle; and one side of the tibial plateau.  The femoral component is made of cobalt chrome and the tibial component is made of titanium with a UHMWPE insert that snaps into place.  The device is non constrained; the articulating surface of the UHMWPE insert is flat and joint stability is maintained by ligaments and other soft tissue surrounding the knee.   The Stride Size 2 Femoral Implant; catalogue numbers PFSI-00053 Right Lateral/Left Medial and PFSI-00054; Right Medial/Left lateral are mislabeled.  Packages labeled PFSI-00053; Right Lateral/Left Medial contains PFSI-00054; Right Media/Left lateral implants.  Packages labeled PFSI-00054; Stride Right Media/Left Lateral contain PFSI-00053; Left Medial/Right Lateral.

Jun-27-2014        Zimmer Manufacturing B.V.        NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component; Precoat – ***LOT***NexGen Complete Knee Solution***MIS Total Knee Procedure***Stemmed***Tibial Component***Precoat***Fixed Bearing***Size*** NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained; non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; Collagen disorders; and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy; Moderate valgus; varus; or flexion deformities; and the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. These devices are intended for cemented use only.      Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Jun-27-2014        Zimmer Manufacturing B.V.        NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component; Precoat – ***LOT***NexGen Complete Knee Solution***MIS Total Knee Procedure***Stemmed***Tibial Component***Precoat***Fixed Bearing***Size*** NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained; non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; Collagen disorders; and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy; Moderate valgus; varus; or flexion deformities; and the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. These devices are intended for cemented use only.      Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Jun-27-2014        Zimmer Manufacturing B.V.        NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component; Precoat – ***LOT***NexGen Complete Knee Solution***MIS Total Knee Procedure***Stemmed***Tibial Component***Precoat***Fixed Bearing***Size*** NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained; non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; Collagen disorders; and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy; Moderate valgus; varus; or flexion deformities; and the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. These devices are intended for cemented use only.      Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Jun-27-2014        Zimmer Manufacturing B.V.        NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component; Precoat – ***LOT***NexGen Complete Knee Solution***MIS Total Knee Procedure***Stemmed***Tibial Component***Precoat***Fixed Bearing***Size*** NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained; non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; Collagen disorders; and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy; Moderate valgus; varus; or flexion deformities; and the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. These devices are intended for cemented use only.      Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Jun-27-2014        Zimmer Manufacturing B.V.        NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component; Precoat – ***LOT***NexGen Complete Knee Solution***MIS Total Knee Procedure***Stemmed***Tibial Component***Precoat***Fixed Bearing***Size*** NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained; non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; Collagen disorders; and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy; Moderate valgus; varus; or flexion deformities; and the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. These devices are intended for cemented use only.      Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Jun-27-2014        Zimmer Manufacturing B.V.        NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component; Precoat – ***LOT***NexGen Complete Knee Solution***MIS Total Knee Procedure***Stemmed***Tibial Component***Precoat***Fixed Bearing***Size*** NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained; non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; Collagen disorders; and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration; particularly when there is patellofemoral erosion; dysfunction or prior patellectomy; Moderate valgus; varus; or flexion deformities; and the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. These devices are intended for cemented use only.      Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.