
Class I recalls
Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
Acclarent; Inc. | Mar-01-2012 | Airway balloon catheter – Inspira AIR Balloon Dilation System;size 18 x 40;Manufactured by Acclarent; Inc.1525-G O’Brien Drive; Menlo Park; CA 94025Product Usage: Dilation of airway tree. | Acclarent received reports of difficulty deflating the balloon during the procedure; which could potentially result in airway obstruction. |
Medtronic MiniMed | Mar-19-2012 | Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets – Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9. (differences in models is variation in length; 6 versus 9mm) | Possibility of interrupted insulin flow. This posting is for a recall that occurred in March 2004; also posted on the FDA website in 2004. |
Thoratec Corporation | Mar-23-2012 | HeartMate II Left Ventricular Assist System – HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief.The Sealed Outflow Graft Bend Relief is provided as a component of the HM II Sealed Outflow Graft; which in turn is a component of the HM II LVAS Implant Kit with Sealed Grafts. A short configuration of the HM II LVAS Sealed Outflow Graft Bend Relief is provided as a stand-along product.Thoratec Corporation6035 Stoneridge DrivePleasanton; CA 94588.Product Usage:The HM II LVAS is intended to provide hemodynamic support in patients with end-stage; refractory left ventricular heart failure; either for temporary support; such as a bridge to Cardiac Transplanation or myocardial recovery; or as permanent destination therapy. The HeartMate II is intended for use inside or outside the hospital. The outflow of the HM II LVAS blood pump is connected to the aorta with a flexible vascular graft. The outflow graft is provided with a bend relief; a three or four in long tube of reinforced ePTFE surrounding the outflow graft proximal to the pump that is designed to prevent kinking of the outflow graft. | A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified |
Class II recalls
Recalling Manufacturer | Date Posted | Trade Name/Product | Reason for Recall |
Alere San Diego | Mar-01-2012 | Drugs of Abuse Screen – Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476); Triage Drugs of AbusePanel Plus TCA (K973784); & Triage Drugs of Abuse Panel Plus PPX (K014247)Model Number: 90008; 92002; & 92000Type of Packaging (i.e. box; plastic bag): For all affected device types: 25 individually pouched devicesin a labeled kit box.The Triage Drugs of Abuse Panel plus Tricyclic Antidepressants utilizes a patented immunochemistry;ASCENDTM MULTIMMUNOASSAY (AMIATM). Each AMIATM assay is a competitive binding immunoassayin which a chemically labeled drug (drug conjugate) competes with drug which may be present in the urine forantibody binding sites. After a brief incubation; the reaction mixture is transferred to the membrane in theDetection Area. Free drug conjugate that is displaced from antibody binding sites by drug in the urine; binds to azone of monoclonal antibody that is immobilized on the membrane. The membrane is washed to remove theunbound conjugate and clear the background. Test results are visually read.The Triage Drugs of Abuse Panel plus Tricyclic Antidepressants is an immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse; (Phencyclidine; Benzodiazepines; Cocaine Metabolite; Amphetamines; THC; Opiates; Barbiturates); and Tricyclic Antidepressants in urine. | Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA. |
Ion Genius; Inc. | Mar-01-2012 | Perfector – PerfectorProduct Usage: Muscle stimulation | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally; devices were sold/distributed without 510(k) or PMA |
Boston Scientific CRM Corp | Mar-01-2012 | LATITUDE Patient Management System Communicator – Boston Scientific; LATITUDE Patient Management System Communicator; Models 6476.The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. | One (1) Model 6476 LATITUDE Communicator is unable to interrogate the patient’s pulse generator. Boston Scientific has determined that this is due to a patient receiving an incorrect communicator. Therefore the communicator did not find and was unable to interrogate the assigned patients PG. Additionally when the patient attempted to set-up this incorrect communicator; the system reflected |
Ion Genius; Inc. | Mar-01-2012 | Arasys – ArasysProduct Usage: Muscle stimulation | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally; devices were sold/distributed without 510(k) or PMA |
Ion Genius; Inc. | Mar-01-2012 | Ion Magnum – Ion MagnumProduct Usage: Muscle stimulation | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally; devices were sold/distributed without 510(k) or PMA |
Ion Genius; Inc. | Mar-01-2012 | IELLIOS – IELLIOSProduct Usage: Muscle stimulation | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally; devices were sold/distributed without 510(k) or PMA |
Ion Genius; Inc. | Mar-01-2012 | iPico – iPicoProduct Usage: Muscle stimulation | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally; devices were sold/distributed without 510(k) or PMA |
Philips Healthcare Inc. | Mar-01-2012 | Philips IntelliVue Patient Monitors – Philips IntelliVue Patient Monitors: The monitor is intended to be used for monitoring and recording of; and to generate alarms for; multiple physiological parameters of adults; pediatrics; and neonates in health care facilities. The monitor is to be used by trained health care professionals. Physiological Monitoring; Patient Monitor ; Arrhythmia detector and alarm (including ST -segment measurement and alarm. | Central station monitors may not alarm (either visual or audible) when an alarm is announced at the affected patient monitor |
Integra LifeSciences Corp. | Mar-02-2012 | Tibiaxys Ankle Arthrodesis Plate Compression Guide – Tibiaxys Ankle Arthrodesis Plate Compression Guide; Model #159635; part # 159 635; Batch #: EAHZ; EAJ1; ELGV; ENQE & ENQH.Product Usage:The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis; osteotomies; and fractures of ankle joint; distal tibia and fibula). | During 6/30/2010 to 8/17/2011 the firm received five (5) incident complaints of breakage of the threaded part of the compression guide which potentially occurred when: 1) a compression is applied between talus and tibia. (Step 3 of the product description) or when 2) the surgeon screws the compression guide into the plate which most likely was attributed to improper surgical techniques used durin |
Biomet; Inc. | Mar-02-2012 | Biomet Signature " TKA GDE/MDL SET 04-05 – REF 42-422561 SIGNATURE QTY; 1 TKA GDE/MDL (Prosthesis; knee) SET 04-05 DGHUMPHR-NOV52LKA-J_K-00432022 SLIDEX DISTAL-MP/PREMIER TIBIAL CUSTOM-MADE DEVICESignature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in the guiding and marking of bone before cutting and to guide cutting; provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. | Biomet has initiated this action following investigation that identified two (2) specific lots of part number 42-422561 were incorrectly labeled. One (1) unit (lot 025640) was received back from distributor’s office as a product complaint. |
Integra LifeSciences Corp. | Mar-02-2012 | Titanium Surfix Alpha Screws – Titanium SURFIX ALPHA SCREWS; a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Variable angle locking system exists in different diameters and lengths. The product can be sold as a replenishment part individually packaged sterile; or as one (1) unit which is kitted within an instrumentation tray at which point; the product is non-sterile until the tray in which it is kitted is sterilized a the designated facility. The product is indicated for use in fixation of fractures; osteotomies or arthrodesis of the first metatarso-phalangeal joint. | Manufacturing error. The part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm. |
Biomet; Inc. | Mar-02-2012 | OSS AVL Poly Tibial Bushing Set – OSS AVL Poly Tibial Bushing SetOSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures. | Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures; and were found to contain two tabbed bushings. |
Olympus America Inc. | Mar-05-2012 | Olympus Mobile Workstations – Olympus Mobile Workstations (Endoscopy Carts); Models WM-DP1; WM-NP1 and WM-WP1The mobile workstations are intended for use in medical facilities under the direction of a trained physician; and has been designed to be used with a range of Olympus equipment to facilitate GI endoscopy; endoscopic ultrasound; respiratory and surgical endoscopic | Replacement wheels may break off from the base of the cart |
Sorin Group USA; Inc. | Mar-05-2012 | S5 Control Panel – S5/C5 Control panel for 2 mast roller pumps 85; Part No.: 28-95-85; Sorin Group Deutschland GMBH; Lindberghstrasse 25; 80939 Munchen; Germany; Sorin Group USA; Inc.; 14401 W. 65th Way; Arvada; CO 80004; USAThe S5 System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six hours. | Touch screen may be unresponsive; inhibiting user input. |
Sorin Group USA; Inc. | Mar-05-2012 | S5 Single Roller Pump 150 – Stockert; S5 Roller pump 150; Part 10-80-00; Sorin Group Deutschland GMBH; Lindberghstrasse 25; 80939 Munchen; Germany; Sorin Group USA; Inc.; 14401 W. 65th Way; Arvada; CO 80004; USAThe S5 System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six hours. | Touch screen may be unresponsive; inhibiting user input. |
Sorin Group USA; Inc. | Mar-05-2012 | S5 Double Roller Pump 85 – Stockert; S5 Double roller pump 85; Part 10-85-00; Sorin Group Deutschland GMBH; Lindberghstrasse 25; 80939 Munchen; Germany; Sorin Group USA; Inc.; 14401 W. 65th Way; Arvada; CO 80004; USAThe S5 System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six hours | Touch screen may be unresponsive; inhibiting user input. |
Sorin Group USA; Inc. | Mar-05-2012 | S5 Control Display Module – Stockert S5 Control and display module; Part No.: 28-95-10; Sorin Group Deutschland GMBH; Lindberghstrasse 25; 80939 Munchen; Germany; Sorin Group USA; Inc.; 14401 W. 65th Way; Arvada; CO 80004; USAThe S5 System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six hours. | Touch screen may be unresponsive; inhibiting user input. |
Sorin Group USA; Inc. | Mar-05-2012 | S5 Control Panel For Mast Roller Pump 85 – S5/C5 control panel for mast roller pump 150/85; Part No.: 28-95-80; Sorin Group Deutschland GMBH; Lindberghstrasse 25; 80939 Munchen; Germany; Sorin Group USA; Inc.; 14401 W. 65th Way; Arvada; CO 80004; USAThe S5 System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six hours. | Touch screen may be unresponsive; inhibiting user input. |
Siemens Medical Solutions USA; Inc | Mar-05-2012 | Siemens Ysio; AXIOM Luminos dRF; AXIOM Luminos Agile/TF; Uroskop Omnia – Siemens Ysio; AXIOM Luminos dRF; AXIOM Luminos Agile/TF; Uroskop OmniaSolid state x-ray imager (flat panel/digital imager) | Firm has become aware of unintended behavior when using Ysio; AXIOM dRF; AXIOM Luminos Agile/TF and Uroskop Omnia with RAD Fluoro Uro function using software version VC10A. Due to an error in the image pipeline; images may display dark and not suitable for diagnostic. Due to this software error customers have to repeat x-ray exposure to receive diagnostic images. |
Sorin Group USA; Inc. | Mar-05-2012 | S5 Mast Roller Pump – Large – SORIN GROUP; Distributed by: Sorin Group USA; Inc.; Arvada; CO 80004; USA; SRD S5 MAST ROLLER PUMP; Made in Germany; 1 UNITS PER CASE; CATALOG/PART No.: 50-80-00The S5 System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six hours. | Touch screen may be unresponsive; inhibiting user input. |
Sorin Group USA; Inc. | Mar-05-2012 | S5 Two Mast Roller Pumps – SORIN GROUP; Distributed by: Sorin Group USA; Inc.; Arvada; CO 80004; USA; SRD S5 TWO MAST ROLLER PUMPS; Made in Germany; 1 UNITS PER CASE; CATALOG/PART No.: 50-80-60The S5 System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six hours. | Touch screen may be unresponsive; inhibiting user input. |
Sorin Group USA; Inc. | Mar-05-2012 | S5 Two Mast Roller Pumps with Coupling – SORIN GROUP; Distributed by: Sorin Group USA; Inc.; Arvada; CO 80004; USA; S5 TWO MAST PUMPS 85 W/ COUPLING; Made in Germany; 1 UNITS PER CASE; CATALOG/PART No.: 50-80-62The S5 System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six hours. | Touch screen may be unresponsive; inhibiting user input. |
Sorin Group USA; Inc. | Mar-05-2012 | S5 Mast Roller Pump – Small – SORIN GROUP; Distributed by: Sorin Group USA; Inc.; Arvada; CO 80004; USA; SDR S5 MAST ROLLER PUMP 85; Made in Germany; 1 UNITS PER CASE; CATALOG/PART No.: 50-80-70The S5 System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six hours. | Touch screen may be unresponsive; inhibiting user input. |
Sorin Group USA; Inc. | Mar-05-2012 | C5 Mobile Console – SORIN C5 CONSOLE Part No.: 58-00-00; SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25; 80939 Munchen; Germany; Sorin Group USA; Inc.; 14401 W. 65th Way; Arvada; CO 80004; USAThe S5 System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six hours. | Touch screen may be unresponsive; inhibiting user input. |
Ormco Corporation | Mar-05-2012 | AdvanSync; an orthodontic expansion screw – AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malocclusions. The AdvanSync part numbers and lot numbers affected by this recall are as follows:Part Number: 600-4000 (Kits-include 10 Right 600-4000 and 10 Left Assemblies). Lot Numbers: 070990588; 070976869; 060971515; 060971514; 04094278DPart Number: 600-4040 (5-Pack; Left Assembly). Lot Numbers: 080901333; 080902356; 070981416; 060971299; 060976084Part Number: 600-4041 (5-Pack; Right Assembly). Lot Numbers: 080902357; 080901335; 070981417; 060971304; 060976079 | Manufacturing Error: There is a potential for a braze joint failure in the upper telescopic rod assembly. Although an incident could occur in which the eyelet loses connection from the rod; there is no risk of swallowing or aspirating the appliance because it will still be attached to the patient’s crown. |
Varian Medical Systems; Inc. Oncology Systems | Mar-06-2012 | Eclipse Treatment Planning System – Eclipse Treatment Planning System; versions 7.3; 8.0; 8.1; 8.2; 8.6; 8.9 and 10.0;Model H48Varian Medical Systems; Palo Alto; CA.Product Usage:The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon; electron and proton beams; as well as for internal irradiation (brachytherapy) treatments. In addition; the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eye. | Varian has been identified an anomaly with the Eclipse Treatment Planning System where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open. |
Pelton & Crane Company | Mar-06-2012 | Pelton & Crane – Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option; 1727 Fuehauf Dr. Charlotte; NC 28273Product Usage:The intended use of the dental operative unit is for supplying power and to serve as a base for other dental devices; such as a dental hand piece; air/water syringe; oral cavity evacuator; a suction operative unit; and other dental devices. The TLC SAFEdrive option is an optional feature that monitors the operation of the high speed hand piece and gives an audible and visual signal to let the user know if the hand piece is potentially damaged or heating up. | Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up. |
Varian Medical Systems; Inc. Oncology Systems | Mar-06-2012 | TrueBeam Radiotherapy Delivery System – TrueBeam and True Beam STx versions 1.0 through 1.5; Model number H19; Varian Medical Systems; Palo; Alto; CA 94304. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions; tumors and conditions anywhere in the body where radiation treatment is indicated. | An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols; the gating thresholds can be reset to default values; rather than retaining the thresholds established during planning. |
DePuy Mitek; Inc.; a Johnson & Johnson Co. | Mar-06-2012 | Depuy Mitek Lupine Loop Plus Anchor w/Orthocord – Depuy Mitek Lupine Loop Plus Anchor w/OrthocordCatalog Number: 210708The Lupine Anchor System is indicated for use in soft tissue bone fixation. | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair |
DePuy Mitek; Inc.; a Johnson & Johnson Co. | Mar-06-2012 | Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl – Depuy Mitek- Lupine Loop Plus Anchor w/ PanacrylCatalog Number: 210707The Lupine Anchor System is indicated for use in soft tissue bone fixation. | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair |
DePuy Mitek; Inc.; a Johnson & Johnson Co. | Mar-06-2012 | Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl – Depuy Mitek- Lupine (Panalok) Loop Arthro #2 PanacrylCatalog Number: 210705The Lupine Anchor System is indicated for use in soft tissue bone fixation. | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair |
DePuy Mitek; Inc.; a Johnson & Johnson Co. | Mar-06-2012 | Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond – Depuy Mitek Lupine (Panalok) Loop Arthro #2 EthibondCatalog Number: 210704The Lupine Anchor System is indicated for use in soft tissue bone fixation. | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair |
DePuy Mitek; Inc.; a Johnson & Johnson Co. | Mar-06-2012 | Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS – Depuy Mitek LupineLoopPlus Anchor w/Orthocord DSCatalog Number: 210709The Lupine Anchor System is indicated for use in soft tissue bone fixation. | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair |
DePuy Mitek; Inc.; a Johnson & Johnson Co. | Mar-06-2012 | Depuy Mitek Lupine Loop DS w/Orthocord – Depuy Mitek Lupine Loop DS w/OrthocordCatalog Number: 222981The Lupine Anchor System is indicated for use in soft tissue bone fixation. | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair |
DePuy Mitek; Inc.; a Johnson & Johnson Co. | Mar-06-2012 | Depuy Mitek- Lupine Loop O-C violet – Depuy Mitek- Lupine Loop O-C violetCatalog Number: 222980The Lupine Anchor System is indicated for use in soft tissue bone fixation. | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair |
DePuy Mitek; Inc.; a Johnson & Johnson Co. | Mar-06-2012 | Depuy Mitek Lupine Loop Plus Anchor w/Ethibond – Depuy Mitek Lupine Loop Plus Anchor w/EthibondCatalog Number: 210710The Lupine Anchor System is indicated for use in soft tissue bone fixation. | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair |
DePuy Mitek; Inc.; a Johnson & Johnson Co. | Mar-06-2012 | Depuy Mitek LUPINE BR W/ORTHCORD – Depuy Mitek LUPINE BR W/ORTHCORDCatalog Number: 210711The Lupine Anchor System is indicated for use in soft tissue bone fixation. | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair |
DePuy Mitek; Inc.; a Johnson & Johnson Co. | Mar-06-2012 | Depuy Mitek LUPINE BR DS W/ORTHCRD – Depuy Mitek LUPINE BR DS W/ORTHCRDCatalog Number: 210712The Lupine Anchor System is indicated for use in soft tissue bone fixation. | Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair |
Beckman Coulter Inc. | Mar-06-2012 | Synchron Phenobarbital (PHE) Reagent – Synchron Phenobarbital (PHE) Reagent; P/N 469785; Classification Product Code: KLT.Subsequent Product Codes: DIP; KLS; LCD; LCQ; LCR; LFN.PHE reagent; when used in conjunction with SYNCHRON LX System(s); UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1; is intended for quantitative determination of Phenobarbital concentration in human serum or plasma. | The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator. |
Beckman Coulter Inc. | Mar-06-2012 | Synchron Phenobarbital (PHE) Drug Calibrator 1 – Synchron Phenobarbital (PHE) Drug Calibrator 1; P/N 469600; Classification Product Code: KLT.Subsequent Product Codes: DIP; KLS; LCD; LCQ; LCR; LFN.The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1; when used in conjunction with SYNCHRON reagents; is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine; Phenobarbital; Phenytoin; Theophylline; and Valproic Acid. | The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator. |
Cell Marque Corporation | Mar-06-2012 | Cell Marque CD7 (MRQ-12); – Cell Marque CD7 (MRQ-12);Mouse Monoclonal Antibody;Antibody is bottle in HDPE bottle with screw cap lid with container label. Then put in cardboard Box with outer box label.Cell Marque; Rocklin; CA 95677;intended for qualified laboratories to qualitatively identify by light microscopy; the presence of associated antigens in section of formalin fixed; paraffin embedded tissue section using manual or automated IHC test methods. Use of this antibody is indicated as an aid in diagnostic determination of human tumors within the context of the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist or physician. | Letter received from supplier that material received in October 2009 was labeled as CD7; but was actually CD 2. |
Siemens Medical Solutions USA; Inc | Mar-07-2012 | Siemens mMLC (ModuLeaf) – Siemens mMLC (ModuLeaf) safety bar and trolley label.Siemens Medical Solutions USA; Inc.Concord; CA.The intended use of the Siemens branded mMLC is an accessory used with the Linear Accelerator systems to deliver x-ray photon and electron radiation for the therapeutic treatment of cancer. This accessory shapes the radiation beam; per the leaf parameters; to minimize the amount of dose to outlying tissue. | This correction is being performed to update the safety knob of the Siemens brand mMLC (ModuLeaf) to conform to tie IEC 60601-1 safety standard. |
Hamilton Medical Inc | Mar-07-2012 | Hamilton-G5 Ventilator – HAMILTON G5 ventilators with software version V2.0x.Hamilton Medical AG; SwitzerlandImported and distributed by Hamilton Medical; 4990 Energy Way; Reno; NV 89502.Product Usage:Hamilton-G5 Ventilators are designed for intensive care ventilation of adult and pediatric patients; and optionally infant and neonatal patients. The devices are intended for use in the hospital and institutional environment with trained healthcare professionals. | Hamilton-G5 ventilators with software version V2.0x may experience an unintentional change of the displayed ventilation mode under certain conditions. |
Siemens Healthcare Diagnostics; Inc | Mar-07-2012 | ADVIA Centaur Intact PTH (iPTH) Assay – ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138)Cat. Nos.100 Test kit 04385983 (129501)500 Test kit 06587575 (129502).For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in EDTA plasma or serum using the ADVIA Centaur systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism; hypoparathyroidism; or hypercalcemia of malignancy. | Poor sensitivity and imprecision on ADVIA Centaur? systems; Serum samples low bias; EDTA plasma samples low bias |
Medtronic Navigation; Inc. | Mar-08-2012 | Left Long Tactile Probe – Left Long Tactile Probe; Part #962009S; Medtronic Navigation; Louisville; CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. | When subjected to bending; twisting; and malleting; the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra. |
Medtronic Navigation; Inc. | Mar-08-2012 | Right Long Tactile Probe – Right Long Tactile Probe; Part #962011S; Medtronic Navigation; Louisville; CO 80027. Trackable handheld instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications. | When subjected to bending; twisting; and malleting; the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra. |
Integra LifeSciences Corp | Mar-08-2012 | Integra InterFix CT Adapter (CTA) – Integra InterFix CT Adapter (CTA)Intended for cranial fixation during CT scanning andtreatment with the TomoTherapy HiArt (Torno) SystemThe Integra InterFix CT Adapter (CTA) kits are intended for cranial fixation during CT and and treatment with the Tomo Therapy Hi-Art system. Provides adapters for attaching: Integra head rings to the following: 1.Flat CT scanner tabletops ranging form 47cm to 54 cm 2. TomoTherapy Hi-Art system tabletop | Material used in the superior region of the InterFix CT Adapter (CTA) has a different density than that of the Treatment Table Couch Adapter (TTA). Resulting dosimetry can be affected if posterior fields are used. Integra estimates that a target dose decrease of 1.2% would result from a typical 360 degree TomoTherapy arc. |
Visionsense; Ltd. | Mar-08-2012 | VSII – Visionsense Stereoscopic Vision System; Brand name VSII; Model/Part Numbers 172-0030 and 172-0040 — Classification Name: Neurological Endoscope — NOTE: Model Numbers 172-0032; 172-0044; 172-0070; 172-0072; 172-0080 were also included in the firm’s recall action but these never entered US commerce. These were distributed directly from Israel to the foreign consignees. — The VSII is intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures. These devices do not carry an expiration date. However; they are automatically taken out of service and replaced after 40 uses. | A complaint was received and a unit returned that exhibited the metal and glass shaft window becoming dislodged during scope cleaning. Additionally; during in-process visual inspection of the metal and glass shaft window sub-assembly from a specific batch that was received from the supplier it was noted that the window at the tip of the scope was not seated properly. It was determined that the wi |
Microsoft Corporation Health Solutions Group | Mar-08-2012 | Microsoft Amalga UIS 2009 – Microsoft Amalga UIS 2009 is Microsoft Amalga Unified Intelligence System (UIS); Calculator/data processing module; for clinical use.Microsoft Amalga UIS 2009 enables healthcare providers to create a comprehensive continually updated data ecosystem to aggregate; store; display; and share disparate data either coming from many source systems or directly entered by end users for rapid self-service data exploration and analysis by front line managers; clinicians and ancillary staff. Furthermore; Amalga UIS allows healthcare providers to rapidly create new applications to respond to evolving business and clinical needs. | The problem occurs when a user filters the data in Amalga datagrid to exclude specific values. If the field specified in the filter criteria contains NULL values; the filtering will exclude those records as well. |
Beckman Coulter Inc. | Mar-08-2012 | SYNCHRON Rheumatoid Factor (RF) Reagent – SYNCHRON Rheumatoid Factor (RF) Reagent; Part Number: 475136A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum; other body fluids; and tissues. | The recall was initiated because Beckman has confirmed that the all in date lots of Synchron Rheumatoid Factor (RF) Reagent might generate false positive results or calibration failures. |
Pointcare Technologies; Inc. | Mar-08-2012 | CD4NOW Gold Reagent Pack – PointCare NOW CD4NOW Gold Reagent Pack; or Gold Pack;Part Number :30034In Vitro Diagnostic : Assay reagent intended for use on the PointCare NOW In Vitro Diagnostics Instrument to provide CD4 positive lymphocytes cell count | Stability not assured at labeled temperature 2-42?C |
Beckman Coulter Inc. | Mar-09-2012 | ACCESS Ostase – ACCESS OstasePart Number: 37300Used for the quantitative measurement of bone alkaline phosphatase (BAP). | The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results. |
Philips Medical Systems Nederlands | Mar-09-2012 | Philips MultiDiagnost Eleva FD – Philips MultiDiagnost Eleva FD; Software R5.1.xModel: 708034Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy; Radiography and Angiography can be performed along with more specialized interventional applications. | Displayed skin dose rate is calculated using an incorrect point of reference; resulting in too low displayed values. |
Philips Medical Systems Nederlands | Mar-09-2012 | Philips MultiDiagnost Eleva II Software Version R4.1 – Philips MultiDiagnost Eleva II Software Version R4.1.xModel: 708032This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy; Radiography and Angiography can be performed along with more specialized interventional applications. | Displayed skin dose rate is calculated using an incorrect point of reference; resulting in too low displayed values. |
Invacare Corporation | Mar-12-2012 | TDX SP Power Wheelchair – TDX SP Power Wheelchair; Model #’s: TDXSP-CG; TDXSP-CG-GT; TDXSP-MCG; TDXSP-MCG-GT; Distributed By:Invacare Corporation; Elyria; OH 44035The Invacare TDX power wheelchair is a battery powered; motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or non-folding type power wheelchair; with mid wheel drive capability. | Invacare Corporation decided to recall the product because use of this actuator could result in reduced cross sectional current carrying area due to wear/chafing of the wires. |
Varian Medical Systems; Inc. | Mar-12-2012 | Regulation Number 892.5700 – Nucletron Adapter and Transfer Guide Tube Set; part number AL 13005001; set of 3 adapters; components used with the VariSource" IX HDR Afterloader.Product Usage: The adapter is part of the VariSource Afterloader System; a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient. | Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients. |
Varian Medical Systems; Inc. | Mar-12-2012 | Regulation Number 892.5700 – Nucletron Adapter and Transfer Guide Tube; part number AL 13005000; a component used with the VariSource" IX HDR Afterloader.Product Usage: The adapter is part of the VariSource Afterloader System; a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient. | Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients. |
Stryker Instruments Div. of Stryker Corporation | Mar-12-2012 | Flat Proximal Pressurizer. – Flat Proximal Pressurizer.Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the cement during delivery. | The firm identified two complaints have been reported indicating that the product inside the package did not match with the label information. The product was labeled as Flat Proximal Pressurizer P/N 0206-556-000 while the product inside the package was Femoral Pressurizer P/N 0206-566-000. |
Intuitive Surgical; Inc. | Mar-13-2012 | da Vinci S. Surgical System; da Vinci Si and da Vinci Si-e Surgical Systems – da Vinci S. Surgical System; da Vinci Si and da Vinci Si-e Surgical Systems.Intuitive Surgical; Inc.Sunnyvale; CA 94086.The Intuitive Surgical Endoscopic instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. | The holding brake; a component of the da Vinci S Surgical System; may allow passive uncontrolled motion due to gravity during specific power-off conditions. |
Stryker Sustainability Solutions; Inc. | Mar-13-2012 | Reprocessed Mitek Arthroscopic Wand – The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue ablators are radiofrequency (RF) surgical tools designed for removal and dissection of tissue in arthroscopic surgeries. A generator or controller serves as the power unit. Soft tissue ablators are available in a wide range of sizes and angles; some models include thermal or suction functions.The outer box of the Reprocessed Mitek Arthroscopic Wand is labeled in part: "***ASCENT HEALTHCARE SOLUTIONS Lakeland; FL***Contents sterile by EO unless package is opened or damaged.***Reprocessed Device for single use. Reprocessed By Ascent Healthcare Solutions.***Cat #: 225301 MITEK 3.5mm SIDE EFFECT ELECTRODE***Lot #: 674290 Expiration Date: 04/2012***"Individual pouch labeled in part: "***Cat #: 225301***MITEK 3.5mm SIDE EFFECT ELECTRODE****IFU at www.ascenths.com***Contents: One Expiration Date 04/2012***Lot # 674201 ID# 0***Reprocessed by Ascent Healthcare Solutions Not affiliated with the original manufacturer.***ASCENT HEALTHCARE SOLUTIONS Lakeland; FL***" | On 06/09/2009; Stryker Sustain ability Solutions; formerly Ascent Healthcare Solutions; recalled lots 674201 & 674290 of their Reprocessed Mitek Arthroscopic Wand due to the lots not being tested in accordance with the functional test requirement during the time frame of 04/14/09 to 05/25/09. |
Mizuho Orthopedic Systems Inc | Mar-13-2012 | Coupler System II – Coupler System IIMizuho Orthopedic Systems; Inc.Union City; CA 94587The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences; referred to as a Mayfield clamp or the radiolucent or aluminum skull clamp referred to as the DORO which is manufactured by pro med instruments Inc. | Mizuho determined that current labeling of The Coupler II system required revisions after investigation of a complaint. |
Smiths Medical ASD; Inc. | Mar-14-2012 | Medfusion 3500 V5 Syringe Pumps – Smiths Medical; Medfusion 3500 Syringe Pumps; Software version 5.0.0; Rx Only; Smiths Medical ASD; Inc.; St. Paul; Minnesota 55112. The Medfusion 3500 Syringe Pump is designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions; drug solutions; blood or blood products; and enteral feedings in continuous; intermittent; and body weight delivery modes. | From August 2007 to August 2010; Smiths Medical received 40 complaints regarding pumps rendered inoperable at power up (displaying a blank screen and alarm).There have been no reports of serious patient injury or death associated with this issue. |
Kerr Corporation | Mar-14-2012 | TempSpan CMT Temporary Cement – Brand Name: TempSpan CMT Temporary Cement; a temporary cement.Part Number: N69CA.The intended use of this device is to affix a temporary dental devices such as crowns or bridges to a tooth. | The recall was initiated because Pentron Clinical has confirmed that the TempSpan Temporary Cement may have black plastic material on the surface of the paste; and it may set faster than specified. |
Carefusion 2200 Inc | Mar-14-2012 | CareFusion Wet PVP-I Preoperative Skin Prep Tray – Wet PVP-I Preoperative Skin Prep Tray containing 1 – 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 – 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 20 trays per case; a sterile; latex-free; single use only tray; solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China; Sponge Stick made in Mexico; CareFusion; McGaw Park; IL 60085 USA; tray catalog number 4468The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren’t appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes; and for washing lacerations and abrasions. | The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps; allowing leakage and also elevated levels of ethylene oxide (EO) sterilant and/or by-products within the PVP-I solution; which may represent a patient safety hazard. |
Carefusion 2200 Inc | Mar-14-2012 | CareFusion Wet PVP-I Small Procedure Preoperative Skin Prep Tray – Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 – 59 mL bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 – 59 mL bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 20 trays per case; a sterile; latex-free; single use only tray; solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China; Sponge Stick made in Mexico; CareFusion; McGaw Park; IL 60085 USA; tray catalog number 4420The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren’t appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes; and for washing lacerations and abrasions. | The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps; allowing leakage and also elevated levels of ethylene oxide (EO) sterilant and/or by-products within the PVP-I solution; which may represent a patient safety hazard. |
Carefusion 2200 Inc | Mar-14-2012 | CareFusion Wet PVP-I Vaginal Preoperative Skin Prep Tray – Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 – 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 – 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 10 trays per case; a sterile; latex-free; single use only tray; solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China; Sponge Stick made in Mexico; CareFusion; McGaw Park; IL 60085 USA; tray catalog number 4469AThe Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren’t appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes; and for washing lacerations and abrasions. | The povidone-iodine (PVP-I) solution bottles in the trays may have loose caps; allowing leakage and also elevated levels of ethylene oxide (EO) sterilant and/or by-products within the PVP-I solution; which may represent a patient safety hazard. |
Philips Healthcare Inc. | Mar-15-2012 | Philips – Philips EasyDiagnost Eleva DRF; Fluoroscopic x-ray systemSoftware Release 3.0 and 3.1Model: 706034Product Usage: Radiological image processing system (computed radiography x-ray system) | Misinterpretation of Mirror Icon-Mirror icon on the bottom of each image could be misinterpreted as aRIGHT lead marker for side indication if the image is mirrored within a PACS system |
Medical Positioning Inc | Mar-15-2012 | MPI Rapid Response HUT Table; Model #RRHUT 1017 – MPI Rapid Response HUT Table; Model #RRHUT 1017. The firm name on the label is Medical Positioning Inc.; Kansas City; MO.Designed for multiple uses including a conventional examination table; unexplained syncope; neurocardiogenic syncope; chronic fatigue syndrome; and most noninvasive procedures. | The warning label regarding electrical shock was not placed on the device warning to have the power switch in the "OFF" position prior to connecting the unit to electric power. |
Medical Positioning Inc | Mar-15-2012 | MPI Rapid Response HUT Table; Model #RRHUT 1217 – MPI Rapid Response HUT Table; Model #RRHUT 1217 with Dual 2 Way Drop Section. The firm name on the label is Medical Positioning Inc.; Kansas City; MO.Designed for multiple uses including a conventional examination table; unexplained syncope; neurocardiogenic syncope; chronic fatigue syndrome; and most noninvasive procedures. With the optional drop section; the use expands to echo/stress echo/Doppler studies; and vascular and carotid echo. | The warning label regarding electrical shock was not placed on the device warning to have the power switch in the "OFF" position prior to connecting the unit to electric power. |
Integra LifeSciences Corp | Mar-15-2012 | Integra – Integra CUSA EXcel Sterile Tips Rx Only Single Use OnlyProduct Usage: For usage in surgical procedures where fragmentation; emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. | A small number of non-conforming CUSA Excel 23 KHz Standard Tip and flue (item Number C4601S) were released for distribution that did not meet Integra’s in-process requirements for release. It was discovered during in-process inspection that the max power reading exceeded the specification of 80 watts; causing the stroke range of the tip to exceed it required range by up a value up to 0.002 inches |
Idev Technologies; Inc. | Mar-15-2012 | Stent Delivery Catheter – SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System.Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms. | The firm is taking this action because the device was one of eight that may have been mislabeled with the incorrect size (length). |
Varian Medical Systems; Inc. Oncology Systems | Mar-16-2012 | FastPlan Treatment Planning System – FastPlan Treatment Planning System; Model HZ3; Varian Medical Systems; Palo Alto; CA. Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer; a printer; a digitizing tablet; and radiation treatment planning application software. | An anomaly has been identified with the CT Localization module of the FastPlan treatment planning system. If the module reports a significant difference in tilt or spin on a slice and the use elects to "Discard" that slice; an incorrect calculation of the isocenter location may result. |
Philips Medical Systems (Cleveland) Inc | Mar-16-2012 | Brilliance Workspace Portal – The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System. The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | Incorrect Standardized Uptake Value ("SUV") values are displayed in two instances:1. After loading PET data (with a Slope value different than 1) into the Quick Review (QR) application from a remote device; and2. During the loading the above mentioned type of PET data into the CT viewer application from a remote device. |
Philips Healthcare Inc. | Mar-16-2012 | DuoDiagnost – DuoDiagnost; model 707015; Universal RF systemProduct Usage: is a mult-functional diagnostic X-Ray system intended for Fluorosopic; Radiographic; Angiographic; and Interventional applications. | The device is currently not compliant with FDA’s amended design criteria for this system; the product is not commercially available in the US. However; it was inadvertently shipped to Puerto Rico due to a logistical error. |
Roche Diagnostics Operations; Inc. | Mar-16-2012 | Elecsys 2010 Analyzer Software version 06-07 – Elecsys 2010 Analyzer Software version 06-07The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids. | Elecsys 2010 customers have reported getting no value and flag 48 results below expected value range after performing automatic dilution for a sample that previously recovered above the measuring range. Incorrect but believable results may occur for the CEA; Rubella IgG or SHBG assays. The other affected assays will generate either no value or a negative result; both of which are not bel |
Biomet U.K.; Ltd. | Mar-19-2012 | Vanguard Distal Cut Block – Vanguard Knee Instrumentation Distal Cutting Block without Handles; REF 32-487002 LOT 2561329; Biomet UK Ltd; South Wales; UKUsed to guide a saw blade in resecting the the distal femor. Intended to be used with a femoral alignment guide guide. | This recall was initiated following a report that a bag labeled as REF. 32-487557/Lot no 2561334 (Vanguard Tibial Resection head universal w/ alignment tower) actually contained a Ref. 32-487002/Lot no. 2561329 (Vanguard Distal cutting Block w/out handle attachment). Investigation found packaging of the affected product may contain the incorrect item. |
Biomet U.K.; Ltd. | Mar-19-2012 | Vanguard Universal Tibial Resection Block – Vanguard Knee Instrumentation Tibial Resection Tower Universal with alignment tower geometry; REF 32487557; LOT 2561334; Biomet UK Ltd; South Wales; UKProduct Usage: Usage: Used to guide a saw blade in resecting the proximal tibia. Intended to be used with a tibial alignment guide. | This recall was initiated following a report that a bag labeled as REF. 32-487557/Lot no 2561334 (Vanguard Tibial Resection head universal w/ alignment tower) actually contained a Ref. 32-487002/Lot no. 2561329 (Vanguard Distal cutting Block w/out handle attachment). Investigation found packaging of the affected product may contain the incorrect item. |
Smith & Nephew; Inc. Endoscopy Division | Mar-19-2012 | BIOSURE HA Interference Screw – Smith & Nephew BIOSURE HA Interference Screw; 7 mm x 25 mmCatalog Number: 72201772.The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures. | Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box;however the device contained in the packaging is a reverse thread screw (P/N 72201773). |
Covidien LP | Mar-19-2012 | DUET TRS Loading Units – Covidien Duet TRS Articulating 60- 3.5MM; Single Use Loading UnitRef: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal; gynecologic and pediatric surgery for resection; transection; and creation of anastomosis. They may be used for transaction and resection of liver substance; hepatic vasculature and biliary structures and for transection and resection of pancreas | Missing component results in the stapler not firing. |
GE Healthcare; LLC | Mar-19-2012 | GE Healthcare Innova – GE Healthcare Innova X-ray Imaging Systems.The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications. | It was discovered that when the Diamentor M4-KDK is installed on an Innova system the dose display is disabled on the certified Innova monitor and enabled on the Diamentor M4-KDK which is not certified as required by FDA regulation (Subpart J). |
Integra LifeSciences Corp. | Mar-19-2012 | EGR (Endoscopic Gastrocnemius Release System – Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit which is kitted within an instrumentation tray. The Integra EGR System includes a range of instruments for endoscopic approach to the Gastrocnemius Aponeurosis Recession. The cutting instrument features a retracting blade for cutting the gastrocnemius aponeurosis. Associated instruments include an elevator; a cannula; and a cannula obturator; which are all consumable instruments provided sterile. The EGR System is indicated for the treatment of posterior heel cord contracture (Equinus) in those patients who fail to respond to conservative management. | The firm received several complaints from customers reporting that the blade of the EGR system may not retract back into the device following surgery. The firm attributes this problem to user error or improper surgical technique on the part of the physician. |
Biosense Webster; Inc. | Mar-20-2012 | CARTO 3 Systems – CARTO 3 Systems; Product Code M-4800-01The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures. | Some CARTO 3 Systems may get radio frequency interference through certain interconnected cable configurations resulting in jumping or disappearing catheter icon and/or error messages during ablation. |
Beckman Coulter Inc. | Mar-20-2012 | SYNCHRON CX(r) systems; Immuno-Protein Calibrator Set – Synchron CX Immuno-Protein Cal; part number: 442840; other product code: CKAThe Beckman Coulter SYNCHRON CX Immune Protein Calibrator Set; in conjunction with SYNCHRON Immuno Protein Reagents; is intended for use on SYNCHRON CX Systems for the calibration of IgA; IgG; IgM; and Transferrin (TRF). | A recall was initiated because Beckman has confirmed that the standardization of the Immuno Protein Calibrator Set has been re-established to IFCC Reference Preparation for Plasma Proteins; BCR-470 beginning with lot number M901330. |
Customed; Inc | Mar-21-2012 | Suture removal kit – Suture removal kit; catalog# 900-010 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Irrigation Tray w/Bulb syringe – Irrigation Tray w/Bulb syringe; catalog# 900-020 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Wound Management Tray – Wound Management Tray Aten cion med. EN El Hogar; catalog# 900-1903 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Wound Management Ryder – Wound Management Ryder; catalog# 900-1605 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Wound Management Tray – Wound Management Tray; catalog# 900-1456 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Wound Management Tray – Wound Management Tray Asoc. Agencia Salud; catalog# 900-1154 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Wound Management Tray – Wound Management Tray; catalog# 900-540 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Prep shave kit; – Prep shave kit; catalog# 900-030 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Universal drainage kit – Universal drainage kit; catalog# 900-032 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Tracheotomy care kit; – Tracheotomy care kit; catalog# 900-110 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Suction Catheter Kit – Suction Catheter Kit; catalog# 900-277 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Urethral Catheter Tray – Urethral Catheter Tray catalog# 900-278 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Incision and Drainage Tray – Incision and Drainage Tray; catalog# 900-774 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Skin Stapler Removal Kit – Skin Stapler Removal Kit ; catalog# 900-782 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Minor laceration tray – Minor laceration tray ; catalog# 900-1765 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Wound Closure Tray – Wound Closure Tray I; catalog# 900-063 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Customed; Inc | Mar-21-2012 | Wound Closure Tray – Wound Closure Tray II; catalog# 900-064 | The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition. |
Ethicon Endo-Surgery Inc | Mar-21-2012 | ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw – ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw; Model # NSLG2S14 and ENSEAL 5 mm Diameter Tissue Sealer G2 25 cm Length Straight Jaw; Model # NSLG2S25. Ethicon Endo-Surgery; LLC Guaynabo; Puerto Rico 00969The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic; general and gynecological surgery to cut and seal vessels; and to cut; grasp and dissect tissue during surgery. Indications for use include open and laparoscopic; general and gynecological surgical procedures (including urologic; thoracic; plastic and reconstructive; bowel resections; hysterectomies; cholecystectomies; gall bladder procedures; Nissen fundoplication; adhesiolysis; oophorectomies; etc.); or any procedure where vessel ligation (cutting and sealing); tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments. | Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL? G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL? device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation |
Ethicon Endo-Surgery Inc | Mar-21-2012 | ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw – ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw; Model # NSLG2C35 and ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 45 cm Length Curved Jaw; Model # NSLG2C45. Ethicon Endo-Surgery; LLC Guaynabo; Puerto Rico 00969The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic; general and gynecological surgery to cut and seal vessels; and to cut; grasp and dissect tissue during surgery. Indications for use include open and laparoscopic; general and gynecological surgical procedures (including urologic; thoracic; plastic and reconstructive; bowel resections; hysterectomies; cholecystectomies; gall bladder procedures; Nissen fundoplication; adhesiolysis; oophorectomies; etc.); or any procedure where vessel ligation (cutting and sealing); tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments. | Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL? G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL? device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation |
Ethicon Endo-Surgery Inc | Mar-21-2012 | ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw; – ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw; Model # NSLG2C14 and ENSEAL 5 mm Diameter Tissue Sealer G2 25 cm Length Curved Jaw; Model # NSLG2C25. Ethicon Endo-Surgery; LLC Guaynabo; Puerto Rico 00969The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic; general and gynecological surgery to cut and seal vessels; and to cut; grasp and dissect tissue during surgery. Indications for use include open and laparoscopic; general and gynecological surgical procedures (including urologic; thoracic; plastic and reconstructive; bowel resections; hysterectomies; cholecystectomies; gall bladder procedures; Nissen fundoplication; adhesiolysis; oophorectomies; etc.); or any procedure where vessel ligation (cutting and sealing); tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments. | Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL? G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL? device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation |
Siemens Healthcare Diagnostics; Inc | Mar-21-2012 | ADVIA Centaur Vitamin D Diluent 2-pack – Siemens ADVIA Centaur Vitamin D Diluent 2-pack;Reference 10494100in vitro diagnostic use in the quantitative determination of total25 (OH) vitamin D in human serum and plasma (EDTA; lithium-heparin; sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systemsThe ADVIA Centaur Vitamin D Total (Vit D) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA; lithium-heparin; sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur Vit Assay is intended as an aid in the determination of vitamin D insufficiency. The ADVIA Centaur Vitamin D Diluent 2-pack is used on board the ADVIA Centaur systems to perform automatic and system-performed dilutions fro Vitamin D assay. | Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causesdiluted patient samples to under recover by approximately 50%. |
Ethicon Endo-Surgery Inc | Mar-21-2012 | ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw – ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw; Model # NSLG2S35. Ethicon Endo-Surgery; LLC Guaynabo; Puerto Rico 00969The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic; general and gynecological surgery to cut and seal vessels; and to cut; grasp and dissect tissue during surgery. Indications for use include open and laparoscopic; general and gynecological surgical procedures (including urologic; thoracic; plastic and reconstructive; bowel resections; hysterectomies; cholecystectomies; gall bladder procedures; Nissen fundoplication; adhesiolysis; oophorectomies; etc.); or any procedure where vessel ligation (cutting and sealing); tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments. | Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENSEAL? G2 Curved and Straight Tissue Sealers due to two potential issues that may occur related to the activation button: (i) Continuous Activation: The ENSEAL? device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) No Activation |
Leica Microsystems; Inc. | Mar-21-2012 | Surgical microscope – Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19; article no. 10448194MO; a component of the Leica M820 C19 Surgical Microscope; article 10448196; and the Leica M844 C19 Surgical Microscope; article 10448197; ceiling mounted surgical microscopes; Leica Microsystems (Schweiz) AG; Max Schmidheiny-Strasse 201; CH-9425; Heerbrugg; Switzerland;; The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. | The screws; which lock the bottom plate to the spindle; pull through allowing the carrier arm with touch panel/control unit of the surgical microscope to disconnect; which potentially could result in them falling. |
Healthtronics; Inc. | Mar-21-2012 | CRYO Care Surgical System – CRYO-206V and CRYO-206F Procedure Kit; which includes: Cryo Probes; Urethral Catheter; and temperature probes.Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold temperatures. | HealthTronics has initiated this recall of these products because there have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances; the label near the prove does not match the label at the connector. If the labeling error went undetected; the TempProbes would not be monitoring temperature in the area believed to be under surveillance. |
Beckman Coulter Inc. | Mar-21-2012 | Access Ostase Calibrators – Access Ostase Calibrators; Part Number: 37305;Subsequent Product Code: JIS.The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems. | The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material. |
Beckman Coulter Inc. | Mar-21-2012 | Access Ostase QC – Access Ostase QC; Part Number: 37309.The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. | The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material. |
Beckman Coulter Inc. | Mar-21-2012 | Access Ostase Reagent – Access Ostase Reagent; Part Number: 37300; subsequent product code: JIS.The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP); an indicator of osteoblastic activity; in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease. | The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material. |
Spectrum Dynamics | Mar-21-2012 | D-SPECT" – D-SPECT" Cardiac Scanner System — COMMON/USUAL NAME: Emission Computed Tomography System — SPECTRUM DYNAMICS — Spectrum Dynamics (Israel) Ltd. 22 Bareket St. North Industrial Park; P.O. Box 3033; Caesarea; 30889 IsraelD-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment; patient and equipment supports; component parts; and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV. | The firm received a report related to the detector housing on the D-SPECT Cardiac Scanner. Specifically; it was reported that if the detector housing securing mechanism is compromised; the detector housing may pull away from its secured position on the gantry and potentially come intocontact with a patient. The reported event was discovered during set up and thus did not involve a patient or p |
Siemens Medical Solutions USA; Inc | Mar-21-2012 | MOSAIQ System; – MOSAIQ System;customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System.MOSAIQ Oncology information system is owned and marketed by IMPAC Medical System; Inc. MOSAIQ is distributed by Siemens Medical Solutions USA; Inc; Radiation Oncology under a distributor contract with IMPAC Medical.Distributed by Siemens Healthcare; Concord; Ca.Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS; ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.P | Images used in treatment planning may belong to another patient. Risk of treatment to wrong area. Software update to upgrade Siemens installed base to the latest release of MOSAIQ version 2.00X3 SP5; for RT Therapist version 2.1A |
Beckman Coulter Inc. | Mar-21-2012 | COULTER LH 750 Analyzer – COULTER LH 750 Analyzer; part number: LH750 System Help 2D1.103272; PN 6605632; PN 6605632R & PN A85570.SW Version 2D1; 2D2.Serial Number: all.The COULTER LH 750 Hematology Analyzer is a quantitative; automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automatedmethod for enumeration of RBCs and WBCs in body fluids. | The recall was initiated because Beckman Coulter has confirmed that the Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C Cell Controls assay sheets using the 2D Barcode scanner. |
Beckman Coulter Inc. | Mar-21-2012 | COULTER LH 500 Series System – COULTER LH 500 Series System ; part number: LH500 System Help 2A4.103271; LH 500 Series System 100V; PN 178832; LH 500 Series System 120V; PN 178833; LH 500 Series System 240V; PN 178834; LH 500 Series System Remanufactured (115V); PN A91062; LH 500 Series System Remanufactured (220V); PN A90994 SW Version 2A4; 2A5. Serial Number: all.The COULTER LH 500 Analyzer is a quantitative; automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH 500 Analyzer also provides a semi-automated reticulocyte analysis. | The recall was initiated because Beckman Coulter has confirmed that the Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C Cell Controls assay sheets using the 2D Barcode scanner. |
Beckman Coulter Inc. | Mar-21-2012 | COULTER LH 780 Analyzer; – COULTER LH 780 Analyzer; part number: LH780 System Help 1B1.103272; PN 723585.SW Version: 1B1; 1B2. Serial Number: all.The COULTER LH 780 Hematology Analyzer is a quantitative; automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. | The recall was initiated because Beckman Coulter has confirmed that the Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C Cell Controls assay sheets using the 2D Barcode scanner. |
Siemens Healthcare Diagnostics | Mar-21-2012 | IMMULITE 2500 CK-MB – IMMULITE 2500 CK-MB L5KCP — Catalog number: L5KCP2 (200 tests); L5KCP6 (600 tests) — Test code: RCK Color: Orange.For in vitro diagnostic use with the IMMULITE 2500 Analyzer — for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum; as an aid in patient management and the assessment of prognosis of myocardial infarction. | Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms. |
Biomet; Inc. | Mar-21-2012 | Micromax Anchors – REF 905463; 2.9 mm Micromax Anchor Long Shaft; Size 2 Blue/White Maxbraid (Lactosorb L-15 resorbable copolymer ) Sterile; EO; Biomet Sports Medicine; Warsaw; INProduct Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone. | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072).This meant that the Indications; Contraindications; Possible Adverse Effects; and some Warnings are not present with the packaged device. |
Biomet; Inc. | Mar-21-2012 | Lactoscrew Anchors – REF 905580; 6. 8 mm Lactoscrew 2#2 MBNo. (Lactosorb L-15 resorbable copolymer ) Sterile; EO; Biomet Sports Medicine; Warsaw; INProduct Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone. | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072).This meant that the Indications; Contraindications; Possible Adverse Effects; and some Warnings are not present with the packaged device. |
Biomet; Inc. | Mar-21-2012 | Lactosorb Anchors – REF 905948; 2.MM Hitch Suture (Lactosorb Anchor L15 2#1;(Lactosorb L-15 resorbable copolymer ) Sterile; EO; Biomet Sports Medicine; Warsaw; INProduct Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone. | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072).This meant that the Indications; Contraindications; Possible Adverse Effects; and some Warnings are not present with the packaged device. |
Biomet; Inc. | Mar-21-2012 | Lactoscrew Anchors – REF 905581; 6.8 mm Lactoscrew 2#2 MB wI NDL; (Lactosorb L-15 resorbable copolymer ) Sterile; EO; Biomet Sports Medicine; Warsaw; INProduct Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone. | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072).This meant that the Indications; Contraindications; Possible Adverse Effects; and some Warnings are not present with the packaged device. |
Siemens Healthcare Diagnostics | Mar-21-2012 | IMMULITE /IMMULITE 1000 CK-MB – IMMULITE /IMMULITE 1000 CK-MB LKMB — Catalog number: LKMB1 (100 tests); LKMB5 (500 tests) — Test code: CMB Color: Dark Blue.For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers — for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum; as an aid in patient management and the assessment of prognosis of myocardial infarction. | Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms. |
Biomet; Inc. | Mar-21-2012 | Micromax Anchors – REF 905571; 5.5 mm Lactoscrew Anchors;WITH Needles #2 Maxbraid (Lactosorb L-15 resorbable copolymer ) Sterile; EO; Biomet Sports Medicine; Warsaw; INProduct Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone. | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072).This meant that the Indications; Contraindications; Possible Adverse Effects; and some Warnings are not present with the packaged device. |
Biomet; Inc. | Mar-21-2012 | Micromax Anchors – REF 905572; 5.5mm Lactoscrew Anchor;WI Maxbraid No Nd (Lactosorb L-15 resorbable copolymer ) Sterile; EO; Biomet Sports Medicine; Warsaw; INProduct Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone. | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072).This meant that the Indications; Contraindications; Possible Adverse Effects; and some Warnings are not present with the packaged device. |
Siemens Healthcare Diagnostics | Mar-21-2012 | IMMULITE 2000/IMMULITE 2000 XPi CK-MB – IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB — Catalog number: L2KMB2 (200 tests); L2KMB6 (600 tests) — Test code: CMB Color: Dark Blue.For in vitro diagnostic use with the IMMULITE 2000 Analyzers — for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum; as an aid in patient management and the assessment of prognosis of myocardial infarction. | Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms. |
Siemens Healthcare Diagnostics | Mar-21-2012 | IMMULITE /IMMULITE Turbo 1000 CK-MB – IMMULITE /IMMULITE Turbo 1000 CK-MB LSKCP — Catalog number: LSKCP1 (100 tests); LSKCP5 (500 tests) — Test code: RCK Color: Orange.For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers — for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum; as an aid in patient management and the assessment of prognosis of myocardial infarction. | Siemens Healthcare Diagnostics has observed that the median for the reference range with current kit lots of the CK-MB assay differs from the guidelines published in the Instructions for Use (IFU). This difference applies to all IMMULITE platforms. |
Biomet; Inc. | Mar-21-2012 | Micromax Anchors; – REF 905570 3.5 mm Lactoscrew Anchor Size 2 white Maxbraid ;(Lactosorb L-15 resorbable copolymer ) Sterile; EO; Biomet Sports Medicine; Warsaw; INProduct Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone. | Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072).This meant that the Indications; Contraindications; Possible Adverse Effects; and some Warnings are not present with the packaged device. |
Codman & Shurtleff; Inc. | Mar-22-2012 | Codman ICP Skull Bolt Kit – Codman ICP Skull Bolt Kit; Product Code: 82-6638. Single Use; disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor; included in the kit. | Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill |
Medtronic Inc. Cardiac Rhythm Disease Management | Mar-22-2012 | EnTrust AT ICD – Medtronic EnTrust; Dual Chamber Implantable; Cardioverter Defibrillator with Atrial and Ventricular Therapies; models D153ATG and D154ATG. The device is indicated for use in ICD patients with atrial tachyarrhythmias; or who are at significant risk of developing atrial tachyarrhythmias. The device is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition; the device is intended to provide pacing; cardioversion; and defibrillation for treatment of patients with symptomatic; drug-refractory atrial fibrillation and/or life-threatening ventricular tachyarrhythmias. Sterile. Medtronic; Inc.; Minneapolis; MN 55432 USA. | A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage. |
Christie Medical Holding Inc | Mar-22-2012 | VeinViewer – VeinViewer (R) by Luminetx; Model Number VV1.0; Part No: P00399-L; Luminetx Corporation; Memphis; TN 38104Product Usage:Non- invasive electronic visual aid device designed to project an image of a superficial subcutaneous vascular structures on the surface of the skin | Instrument may tip over if not moved correctly. |
Stryker Howmedica Osteonics Corp. | Mar-22-2012 | Osteonics Shoulder Glenoid Spanner – Osteonics Shoulder Glenoid SpannerHowmedica Osteonics Corp.325 Corporate DriveMahwah; NJ 07430.The Solar Upper Extremity System Hemi and Total Shoulder Arthroplasty system is designed to address the most common arthritic disorders affecting the shoulder. The spherical reamer is used to prepare the glenoid fossa and provide a uniform surface for instrumentation and implant placement. The glenoid fossa is then sized using surface templates to confirm the appropriate coverage; size and curvature has been determined. To achieve this in surgery; the spherical reamer (5900-2050/-2051/-2052/-2053) must be attached to the Angled Glenoid Driver (5900-2040) by threading the reamer’s male threads into the driver’s female threads. The spherical reamers come in sizes 5; 7; 9 & 11; each with a captive drill head screw (5900-2054/-2055). The spanner features two kidney shaped male lobes that mate with two similar kidney shaped female slots in the screw’s head and is used to tighten and loosen the spherical reamers with the angled driver. These instruments are part of the Solar Total Shoulder Instrument set and can be found in Surgical Protocol LSPUE-4 dated 10/04. Each set contains one spanner that universally fits all size reamers. | Two product complaints reported that the Glenoid Reamer Spanner (Lot F3W7017) would not properly connect to the Glenoid Spherical Reamer. |
Christie Medical Holding Inc | Mar-22-2012 | VeinViewer – VeinViewer (R) by Luminetx; Model Number VV1.1 GS; Part No. P00800-L; Luminetx Corporation; Memphis; TN 38104Product Usage: CTS Usage:Non- invasive electronic visual aid device designed to project an image of a superficial subcutaneous vascular structures on the surface of the skin | Instrument may tip over if not moved correctly. |
Medtronic Inc. Cardiac Rhythm Disease Management | Mar-22-2012 | EnTrust VR ICD – Medtronic EnTrust; Single Chamber Implantable; Cardioverter Defibrillator with Ventricular Therapies; models D153VRC and D154VRC. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment for automated treatment of life-threatening ventricular arrhythmias. Sterile. Medtronic; Inc.; Minneapolis; MN 55432 USA. | A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage. |
Medtronic Inc. Cardiac Rhythm Disease Management | Mar-22-2012 | EnTrust DR ICD – Medtronic EnTrust; Dual Chamber Implantable; Cardioverter Defibrillator with Ventricular Therapies; models D153DRG and D154DRG. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment for automated treatment of life-threatening ventricular arrhythmias. Sterile. Medtronic; Inc.; Minneapolis; MN 55432 USA. | A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage. |
Permobil Inc | Mar-22-2012 | Permolock C3 – Permolock C3; Docking system for Power wheelchair in vehicle.Intended use: locking device | The fasteners used between June 3; 2011 and January 31; 2012 to attach the Permolock C3 pins to wheelchairs manufactured in the United States do not contain the required nylon ring; which allows for a more secure attachment. |
Ortho-Clinical Diagnostics | Mar-22-2012 | VITROS – VITROS Chemistry Products — ALT Slides — [REF] 165 5281 — [Mfg Symbol] Ortho-Clinical Diagnostics; Inc.; Rochester; NY USA. The recalled device is the calibration disk contained within the VITROS Calibrator Kit 3. The is can be identified with the label "VITROS Chemist y Systems — Universal Calibration Diskette — [REF] 871 6607 — Ortho-Clinical Diagnostics"For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 3 is used to calibrate VITROS 250/350/950/5;1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of AcP; ALT; ALKP; AMYL; AST; CK; GGT; LDH; and LIPA. | Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that were known to be outside of the measuring (reportable) range (> 1000 U/L) when using Calibration Diskette/Assay Data Diskette Data Release Version (DRV) 5653 through 5666 and VITROS? Chemistry Products ALT Slides; Generation (GEN) 26 (Product Code 1655281). |
Philips Medical Systems (Cleveland) Inc | Mar-23-2012 | Brilliance 64 and Ingenuity CT – Whole body Computed Tomography X-Ray System (Brilliance 64 and Ingenuity CT); Brilliance 64 M/N 728231; Ingenuity CT M/N 728326; Dist. By Philips Medical Systems; Cleveland; OH | A number of non-conformances were identified during internal and external validation testing of the Brilliance 64 and Ingenuity CT systems with software version Beta 3 (version 4.0.0.xx368). |
Becton Dickinson & Co. | Mar-23-2012 | Fildes Enrichment – Fildes Enrichment; BBL brand; catalog #211866; in 5 ml tubes;10 tubes/package; manufactured by BD Diagnostic Systems; 250 Schilling Circle; Cockeysville; MD 21030.Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. | In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended. |
Qrs Diagnostic | Mar-23-2012 | QRS Diagnostic Universal ECG 12 Channel ECG (IEC); – QRS Diagnostic Universal ECG 12 Channel ECG (IEC); Rx only; REF Z-7000-0400; Manufactured for QRS Diagnostic; 14755 27th Ave North; Plymouth; MN 55447 USA.Product Usage:The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only; for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed; edited; distributed electronically or printed. No real time monitoring or alarm capability is provided. | QRS Diagnostic has initiated a recall involving Universal ECG 12 Lead IEC ECG Devices. This recall has been initiated because the chest lead wires on these devices may have been improperly labeled. Incorrect labeling of the lead wires could result in improper lead wire placement on the patient which may result in inaccurate waveforms being displayed to the user and an inaccurate interpretatio |
Biomet Microfixation; LLC | Mar-23-2012 | Bone Plate – Product is labeled in part: "***REF: 01-7036; LOT 999999; "1.5MM" SYSTEM PLATE L-SHAPE; 3 X 3 HOLE; 100 DEGREE; QTY 00001; CE 0086; 2010-04 *** NON-STERILE PRODUCT ***; LEFT; X-LONG; 0.6 MM TITANIUM; BIOMET MICROFIXATION; 1540 TRADEPORT DRIVE; JACKSONVILLE; FL 32218 USA; 01-736; LOT 999999; QTY 00001; L-SHAPE; 3 X 3 HOLE; 100 DEGREE; LEFT; X-LONG; 0.6 MM; CE 0086.***"Product Usage – CTS Usage:Bone-plate – internal fixation devices intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. | On 4/26/10 Biomet Microfixation; Jacksonville; FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate; Model #01-7036; Lot #193690. Product is labeled incorrectly. |
Philips Medical Systems Gmbh; DMC | Mar-23-2012 | Philips Easy Diagnost Eleva DRF – Philips Easy Diagnost Eleva DRF; Software release 4.0Fluoroscopic image-intensified Stationary X-Ray System. | Underexposed image due to lag in switching betweenauxiliaries |
Medtronic Vascular; Inc. | Mar-23-2012 | Talent Thoracic Stent Graft System – Talent Captivia Stent Graft System – FreeFlow configurations only.Model numbers affected have the following designation:TFXXXXXXXXCP and TBXXXXXXXXCP.Medtronic Inc.Santa Rosa; CA 95403.The Talent Thoracic Stent Graft System is designed to treat thoracic aortic aneurysms using an endovascular approach. When placed within the target lesion; the stent graft provides an alternative conduit for blood flow within a patients vasculature by excluding the lesion from blood flow and pressure. | Complaints received related to the inability/difficulty to release the proximal (FreeFlow) bare stent using the tip capture mechanism. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip; wire-reinforced with 0580178 luer port 8.0mm (24Fr) OD with 3/8" connector; 14" (36cm) longProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.Product Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula without suture flange Angled tip; wire-reinforced with luer port 8.0mm (24Fr) OD with 3/8" connector; 14" (36cm)Product Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.long; with Xcoating" surface coating | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns"Soft-Flow Aortic Cannula without suture flange Angled tip; wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector; 14" (36cm) longProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula without suture flange Angled tip; wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector; 14" (36cm) long; with Xcoating"surface coatingProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula without suture flange Angled tip; wire-reinforced 8.0mm (24Fr) 00 with 3/8" connector; 14" (36cm) long; with Xcoating"surface coatingProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula without suture flange Angled tip with luer port 80mm (24Fr) 00 with 3/8" connector;12" (31cm) longProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula without suture flange Angled tip 8.0mm (24Fr) 0D with 3/8" connector; 12" (31cm) longProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula with suture flange Angled tip; wire-reinforced 8.0mm (24Fr) OD with 3/8" connector; 14" (36cm) longProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula with suture flange Angled tip; wire-reinforced with luer port 8.0mm (24Fr) OD with 3/8" connector; 14" (36cm) longProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 8.0mm (24Fr) OD with 3/8" connector; 12" (31 cm) longProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) OD with 3/8" connector; 12" (31cm) longProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula with suture flange Angled tip; wire-reinforced 7.0mm (21 Fr) OD with 3/8" connector; 14" (36cm) longProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula with suture flange Angled tip; wire-reinforced with luer port 7.0mm (21 Fr) OD with 3/8" connector; 14" (36cm) longProduct Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula with suture flange Angled tip 7.0mm (21 Fr) OD with 3/8" connector; 12" (31cm) lonqProduct Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 7.0mm (21 Fr) OD with 3/8" connector; 12" (31cm) longProduct Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula without suture flange Angled tip; wire-reinforced 6.0mm (18Fr) OD with 3/8" connector; 14" (36cm) longProduct Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula without suture flange Angled tip; wire-reinforced with luer port 6.0mm (18Fr) OD with 3/8" connector; 14" (36cm) longProduct Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula without suture flange Angled tip; wire-reinforced with luer port 6.0mm (18Fr) OD with 3/8" connector; 14" (36cm) long; with Xcoating" surface coatingProduct Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula with suture flange Angled tip; wire-reinforced with luer port 6.0mm (18Fr) OD with 3/8" connector; 14" (36cm) longProduct Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Glendale Memorial Fx Pack – Glendale Memorial XCoated PackProduct Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Glendale Memorial Fx Pack – Glendale Memorial XCoated PackProduct Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula with suture flange Angled tip with luer port 8.0mm (24Fr) OD with 3/8" connector; 8.75" (22cm) longProduct Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula; Aortic cannula; 7.0 mm (21 Fr) OD with 3/8" connector; 14" (36 em) long; with X Coating" surface coating.Product Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.Product Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula; Aortic cannula; 7.0 mm (21 Fr) OD with 3/8" connector; 14" (36 em) long.Product Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula; Aortic cannula; 7.0 mm (21 Fr) OD with 3/8" connector; 14" (36 em) long; with X Coating surface coating.Product Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Glendale Memorial Fx Pack – Glendale Memorial Fx PackProduct Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula; Aortic cannula; 7.0 mm (21 Fr) OD with 3/8" connector; 12" (31 em) long.Product Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Terumo Cardiovascular Systems Corporation | Mar-23-2012 | Sarns Soft-Flow Aortic Cannula – Sarns Soft-Flow Aortic Cannula; Aortic cannula; 7.0 mm (21 Fr) OD with 3/8" connector; 14" (36 em) long.Product Usage: CTS Usage:The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures. | During in-house inspection; Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip; just above the suture ball. |
Ortho-Clinical Diagnostics | Mar-26-2012 | VITROS – VITROS Chemistry Products — dHDL Slides — Ortho Clinical Diagnostics; a Johnson&Johnson company — [Mfg Symbol] Ortho-Clinical Diagnostics; Inc.; Rochester; NY USA — VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. — Product codes: 6801895 (60 slide count); 6802469 (18 slide count) — indicated to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. | Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type. |
RAYSEARCH LABORATORIES AB | Mar-26-2012 | RayStation – RayStation Version 2.0.0.15; Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen 25; SE-111 34 Stockholm Sweden. support@raysearchlabs.comDesigned for treatment planning and analysis of radiation therapy. | An issue was found with the dose calculation in the RayStation 2.0; that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient. |
Penlon; Ltd. | Mar-26-2012 | Penlon Prima Anaesthesia Machines (SP2 and SP3) with Electronic Flowmeter Display – Anesthesia Machines (digital display assembly); A gas machine for anesthesia is a device used to administer to a patient; continuously or intermittently; a general inhalation anesthetic and to maintain a patient’s ventilation. | Penlon; Ltd has identified the potential for the premature failure of a component in some Electronic Flowmeter sensor display unit PCB assemblies. |
Terumo Cardiovascular Systems Corporation | Mar-27-2012 | Terumo Advance Perfusion System 1 – Terumo Advanced Perfusion System 1 Base; 100/120V; Catalog 801763; 6 " Roller Pump Occlusion: Reference AA-2011-015 C. Indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures. | Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery. There has been one report of the pump jamming during a case that concluded with an adverse patient outcome; although there was no indication that the pump jam contributed to the adverse patient outcome. |
Philips Healthcare Inc. | Mar-27-2012 | Philips Healthcare EasyDiagnost Eleva DRF 4.0 – Philips Healthcare EasyDiagnost Eleva DRF 4.0Stationary X-Ray System with DRF as an option for digital radiography. | It was discovered in some instances the detector did not reset as quickly as the user prompted a change form one image receptor (auxiliary) to the next; and then back again. |
Terumo Cardiovascular Systems Corporation | Mar-27-2012 | Terumo Advance Perfusion System 1 – Terumo Advanced Perfusion System 1 Base; 220/240V; Catalog 801764; 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion; regional perfusion; and cardiopulmonary bypass procedures. | Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery. There has been one report of the pump jamming during a case that concluded with an adverse patient outcome; although there was no indication that the pump jam contributed to the adverse patient outcome. |
Biomet Microfixation; LLC | Mar-27-2012 | LactoSorb Heat/Contouring Pen – The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. Product is labeled in part: "***REF 915-3100 LOT***LACTOSORB* SYSTEM HEAT/CONTOURING PEN AND TIPS***QTY 00001***STERILE R STERILE EO***PVC; BRASS***WARNING: DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS. FIRE COULD RESULT.***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE; JACKSONVILLE; FL 32218 USA***#915-3100 LOT***QTY 00001; HEAT/CONTOURING PEN AND TIPS***PVC; BRASS***".Product Usage: Two tips are provided with the body of the device to cut / contour the edges of the LactoSorb plates by heating the material. | On 11/15/2011 Biomet Microfixation; Jacksonville; FL initiated a recall of their Acticort Heat/Contouring Pen; Model #915-3100; Lot #861200. Product is incorrectly labeled |
Becton Dickinson & Co. | Mar-27-2012 | BD BBL ™ Lowenstein-Jensen Medium Deeps – BD BBL ™ Lowenstein-Jensen Medium Deeps; Catalog #221256; packaged in boxes of ten/600 mL tubes. Product Usage: Lowenstein-Jensen Medium is used for the isolation and cultivation of mycobacteria. The medium tubed as deeps is used for the semi-quantitative catalase test as an aid to the classification of mycobacteria. | Media fails to perform as intended with quality control organism Mycobacterium kansasii. |
Cook; Inc. | Mar-28-2012 | Sydney IVF Culture Oil – Sydney IVF Culture Oil; REF; K- SICO- 50; 50 mL. and K-SICO-200; 200 mL;Store at 2-8 C; Sterile; Cook Medical; William A Cook Australia LTD; Product Usage:Culture oil is intended to be used as an oil overlay for cultures of gametes; zygotes; or embryos in assisted reproductive technology (ART) and micro manipulation procedures. It is used to reduce the osmotic stress due to evaporation and to reduce pH fluctuations. | Cook Medical is recalling Sydney IVF Culture Oil due to a number of recent customer complaints that have identified it as a possible cause of embryo degeneration at day 5/6. |
Aerolase | Mar-29-2012 | Aerolase lasers – Aerolase Corporation. The products involved are the FriendlyLight YAG lasers; a Model Family first identified and reported.The products are marketed under names including FriendlyLight Er:YAG; LightPod Era; FriendlyLight Nd:YAG; LightPod Neo; LightPod Neo XL; LightPod Neo XT; LightPod Forte; LightPod Allure; and LightPod Nova. | It was discovered that customers were not supplied with a procedure and schedule for calibrating the FriendlyLight YAG lasers. |
Oridion Medical 1987 Ltd. | Mar-29-2012 | Oridion – Oridion CO2 sampling lines and water traps under the label:Omnistream CO2 Sampling Lines:OmniLine O2 Adult Part No.007609;OmniLine O2 Pediatric Part No 007610;Smart OmniLine Plus O2 Adult Part No.010177;Smart OmniLine Plus O2 Adult (package of 100 units) Part No.010213;Smart OmniLine O2 Pediatric Part No. 007606;;Smart OmniBloc O2 Part No. 010946Smart OmniLine Plus part No. 010172Smart OmniLine Plus (package of 100 units) Part No 010212;Smart OmniLine Guardian O2 Part No. 012531;Smart OmniLine Guardian O2 Long Part No. 012532OmniVentLine Set Part No. 012495 | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. |
Sorin Group Deutschland GmbH | Mar-29-2012 | Pump control panel. – Pump control panel.The S5 Perfusion System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. |
Oridion Medical 1987 Ltd. | Mar-29-2012 | Oridion – Oridion CO2 sampling lines and water traps under the label:MicroStreamC02 Sampling Lines:FilterLine Set Adult/Pediatric -Part No: XS04620-01;FilterLine Set Adult/Pediatric (100 unit boxes)-Part No. 010579;FilterLine H Set Adult/Pediatric -Part No. XS04624 ; FilterLine H Set Adult/Pediatric (100 unit boxes) Part No: 010580;FilterLine H Set Infant/Neonatal-Part No. 006324;FilterLine Set Adult/Pediatric Long Part No. 007768;FilterLine H Set Adult/Pediatric Long Part No. 007737;FilterLine H Set Infant/Neonatal Long Part No. 007738Smart CapnoLine Plus (O2 connector) Part No. 009818Smart CapnoLine Plus (O2 connector) (Special 100 unit boxes) -Part No.; 010209;Smart CapnoLine Plus Long (O2 connector) Part No. 010340;Smart CapnoLine Plus Long (O2 connector) (Special100 unit boxes) Part No: 010339;Smart CapnoLine Plus O2 (O2 tubing) Part No. 009822Smart CapnoLine Plus O2 (O2 tubing) (Special 100 unitboxes) Part No. 010210;Smart CapnoLine Plus O2 Long (O2 tubing) Part No. 009826;Smart CapnoLine Plus O2 Long (O2 tubing) (Special100 unit boxes) ; Part No. 010341;Smart CapnoLine Pediatric Part No. 007266Smart CapnoLine O2 Pediatric (O2 tubing) Part No. 07269;Smart CapnoLine O2 Pediatric Long (O2 tubing) Part No.007743;Smart CapnoLine H Plus O2 (O2 tubing) Part No. 010433;Smart CapnoLine H O2 Adult (O2 tubing) Part No. 010478;Smart CapnoLine H O2 Intermediate (O2 tubing) Part No; 010475;Smart CapnoLine H Pediatric (O2 connector) Part No. 010581;Smart CapnoLine H O2 Pediatric (O2 tubing) Part No. 010582O2 CO2 Nasal FilterLine Adult (O2 connector) Part No. 010207;O2 CO2 Nasal FilterLine Adult (O2 tubing) Part No. 006912;O2 CO2 Nasal FilterLine Adult Long (O2 connector) Part No. 010342;O2 CO2 Nasal FilterLine Adult Long (O2 tubing) Part No. 007739;O2 CO2 Nasal FilterLine Pediatric (O2 tubing) Pat No. 006913;O2 CO2 Nasal FilterLine Long (O2 tubing) Part No 007740;NIV Line Adult Part No. 008174;NIV Line Pediatric Part No. 008175;Nasal FilterLine Infant/Neonatal Part No. XS0447;CapnoLine H Adult Part No. 008177;CapnoLine H Pediatric Part No. 008178;CapnoLine H Infant/Neonatal Part No. 008179;CapnoLine H O2 Adult (O2 tubing) Part No. 008180;CapnoLine H O2 Pediatric (O2 tubing) Part No. 008181;CapnoLine H O2 Infant/Neonatal (O2 tubing) Part No. 012111;VitaLine H Set Adult/Pediatric Part No. 010787;VitaLine H Set Infant/Neonatal Part No. 010807;FilterLine XL Part No. 006325;Smart CapnoLine Guardian Part No. 012528;Smart CapnoLine Guardian O2 Part No. 012529;Smart CapnoLine Guardian O2 Long Part No. 012530 | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. |
Oridion Medical 1987 Ltd. | Mar-29-2012 | Oridion – Oridion CO2 sampling lines and water traps under the label:Surestream CO2 Sampling Lines:SureLine Adult Part No.010976;sureLine Pediatric Part No. 010977;SureLine O2 Adult Part No.010979;SureLine O2 Pediatric Part No.010980Smart SureLine Plus O2 Adult Part No. 010981;Smart SureLine O2 Pediatric Part No. 010982;Smart SureBloc O2 Part No. 010983;Watertrap (package of 25 units) Part No. 010994;Sure VentLine Set Adult/Pediatric Part No.010986;Sure VentLine H Set Adult/Pediatric Part No.010987;Smart SureLine Guardian O2 Part No.012533;Smart SureLine Guardian O2 Long Part No.012534; | CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification. |
Sorin Group Deutschland GmbH | Mar-29-2012 | Sorin C5 (perfusion system) – Sorin C5 (perfusion system)The S5 Perfusion System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. |
Sorin Group Deutschland GmbH | Mar-29-2012 | S5 Single Roller Pump 150 – S5 Single Roller Pump 150The S5 Perfusion System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. |
Sorin Group Deutschland GmbH | Mar-29-2012 | S5 Double Roller Pump 85 – S5 Double Roller Pump 85The S5 Perfusion System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. |
Sorin Group Deutschland GmbH | Mar-29-2012 | Control panel for mast roller pump 150/85 – Control panel for mast roller pump 150/85The S5 Perfusion System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. |
Sorin Group Deutschland GmbH | Mar-29-2012 | Control panel for mast roller pump 85 – Control panel for mast roller pump 85The S5 Perfusion System is used to perform; control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. | The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. Insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. Excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft. |
Hamamatsu Corporation | Mar-29-2012 | Hamamatsu Microfocus X-ray Source – Hamamatsu Corporation; Bridgewater NJ 08807 Microfocus X-ray SourceL8601 series; L9121 series (90kV type MICROFOCUS X-RAY SOURCE);L7901 series; and L8031 series (100kV type MICROFOCUS x-ray source | It was discovered that the Micro Focus X-ray Source could be experiencing software related problems that would allow the unit to exceed the maximum power setting that was set by the operator. |
Philips Healthcare Inc. | Mar-29-2012 | Philips Healthcare MD Eleva system – Philips Healthcare MD Eleva system.Multi-functional fluoroscopy; radiography and angiography systems that can perform more specialized interventional applications | It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface. |
Fresenius Medical Care Holdings; Inc. | Mar-30-2012 | Optiflux F160NRe Hemodialyzer – Fresenius Optiflux F160NRe HemodialyzerCatalog number: 0500316EIntended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. | Risk of internal blood leaks affecting the hemodialyzers. |
Straumann USA; LLC | Mar-30-2012 | Straumann Standard Plus Implant – Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mmArticle Number: 043.652S.Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved; with appropriate occlusal loading; in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients; four or more implants must be used. | Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN |
Philips Medical Systems (Cleveland) Inc | Mar-30-2012 | Brilliance Workspace IntelliSpace Portal; – Brilliance Workspace IntelliSpace Portal; M/N 728269; Mfr. By: Philips Medical Systems; Cleveland; OHThe Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. | A number of non-conformances were logged for IntelliSpace Portal running software version 4.0 during in-house random verification testing. When loading a study to Review; after failing to load it through Add to Running Application the Analysis application is not being closed and different (1st loaded study) patient appears in analysis (CCA). |
Medtronic Neuromodulation | Mar-30-2012 | Medtronic; Model 8870; Application Software Card – Medtronic; Model 8870; Application Software Card is part of the SynchroMed II Drug Infusion System. The System includes the SynchroMed II implantable drug infusion pump 8637-20; 8637-40; N’Vision clinical programmer 8840 and the Software application card 8870. The SynchroMed II Infusion system contains and administers prescribed drugs to a specific site inside patient body. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes. In the United States; the SynchroMed II Pump is specifically approved for (indicated): The chronic epidural/intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain. The chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. The chronic intrathecal infusion of Prialt (preservative-free ziconotide sterile solution) for the management of severe chronic pain. The chronic intravascular infusion of floxuridine (FUDR) for the treatment of primary or metastatic cancer. The chronic intravascular infusion of methotrexate for the treatment of primary or metastatic cancer. Outside of the United States; the SynchroMed II Pump is indicated for the chronic infusion of drugs or fluids tested as compatible and listed in the product labeling for the specific geographies. | Medtronic has confirmed that an algorithm used in the Model 8870 application card software has resultedin nine (9) occurrences of an incorrectly displayed Schedule to replace the pump by date. It is estimated that there are more than 140;000 SynchroMed II pump implants worldwide. A patient with a pump reaching EOS prior to replacement may experience the return of underlying symptoms and/orwit |
Optovue Inc. | Mar-30-2012 | Cornea Power Kit (software) – RTVue CAM with Corneal Power Measurement; Cornea Power Kit (software) | A few doctors in the US were inadvertently sent the Cornea Power software version kit for international users instead of the domestic version. |
bioMerieux; Inc. | Mar-30-2012 | BacT/ALERT Blood Collection Adapter – BacT/ALERT Blood Collection AdapterThe BacT/ALERT Adapter Cap is intended for use as an aid to facilitate filling of blood into the BacT/alert Blood Culture Bottle when using a butterfly blood collection set. | The BacT/ALERT Blood Collection Adapter Cap is no longer compatible with Becton Dickinson (BK) Vacutainer Safety Lok Blood Collection Set. The incompatibility is the blood collection set needle backing out of the adapter cap that results in an exposed sheathed needle that may lead to an accidental needlestick. |
Oridion Medical 1987 Ltd. | Mar-30-2012 | Oridion – Oridion Surestream CO2 Sampling Lines-Sure VentLine Set Adult/PediatricPart Number: 010986-03Product Usage:The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients. | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet |
Oridion Medical 1987 Ltd. | Mar-30-2012 | Oridion – Oridion Surestream CO2 Sampling Lines-SureLine O2 Part Number: 010979-03Product Usage:The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients. | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet |
Oridion Medical 1987 Ltd. | Mar-30-2012 | Oridion – Oridion Surestream CO2 Sampling Lines-Smart SureLine Plus O2 adultPart Number: 010981-03Product Usage:The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients. | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet |
Oridion Medical 1987 Ltd. | Mar-30-2012 | Oridion – Oridion Surestream CO2 Sampling Lines-SureLine AdultPart Number: 010976-03Product Usage:The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients. | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet |
Oridion Medical 1987 Ltd. | Mar-30-2012 | Oridion – Oridion Surestream CO2 Sampling Lines-Sure VentLine H Set Adult/PediatricPart Number: 010987-03Product Usage:The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients. | Surestream CO2 Sampling Lines-Connector may cause breakage of the microswitch inside the CO2 inlet |
Stryker Medical Division of Stryker Corporation | Mar-30-2012 | Stryker Secure II Bed – Stryker Secure 3002; 115 V ~ 60 Hz; 500 lbs ( 227Kg); Stryker; Kalamazoo; MI 49001 Product Usage:Med/Surg beds are AlC powered hospital beds; intended for clinician use; which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The Secure II model is primarily used in the Med/Surg units; but may also be found in a Critical Care environment. | The Brake Plate Body installed on Secure II and EPIC units since November 21st 2007; and installed on units upgraded manufactured between 9/1/2004 through 11/20/2007; demonstrated a component life of approximately 2 years of simulated use. While the correct brake plates were installed on these beds; updated maintenance information was not included. Failure to maintain the bed brakes including th |
Stryker Medical Division of Stryker Corporation | Mar-30-2012 | Stryker Epic Zoom Critical Care bed – Stryker Epic Zoom Critical Care Bed -Model 2040; 115 V; 500 lbs ( 227 Kg) Stryker; Portagwe Mi 49002Product Usage:EPIC II (model 2040) Critical Care beds is primarily used in a Critical Care environment; but may be used in Med/Surg environments. | The Brake Plate Body installed on Secure II and EPIC units since November 21st 2007; and installed on units upgraded manufactured between 9/1/2004 through 11/20/2007; demonstrated a component life of approximately 2 years of simulated use. While the correct brake plates were installed on these beds; updated maintenance information was not included. Failure to maintain the bed brakes including th |
Stryker Medical Division of Stryker Corporation | Mar-30-2012 | Epic Critical Care Bed (Model 2031) – Stryker Critical Care Bed Model 2031; 230 V ; 50/60 Hz; Max Load = 225 Kg;; Stryker; Portage; MIProduct Usage:EPIC II (model 2031 ) Critical Care beds Med/Surg beds are AlC powered hospital beds; intended for clinician use; which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The EPIC II model is primarily used in a Critical Care environment; but may be used in Med/Surg environments. Model 2031 represent International Voltage configurations of the 2030 model respectively. | The Brake Plate Body installed on Secure II and EPIC units since November 21st 2007; and installed on units upgraded manufactured between 9/1/2004 through 11/20/2007; demonstrated a component life of approximately 2 years of simulated use. While the correct brake plates were installed on these beds; updated maintenance information was not included. Failure to maintain the bed brakes including t |
Stryker Medical Division of Stryker Corporation | Mar-30-2012 | Epic – Stryker Epic Critical Care Bed (Model 2030); Stryker; Portage; MI 49002Product Usage:EPIC II (model 2030) Critical Care beds Med/Surg beds are AlC powered hospital beds; intended for clinician use; which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The EPIC II model is primarily used in a Critical Care environment; but may be used in Med/Surg environments. | The Brake Plate Body installed on Secure II and EPIC units since November 21st 2007; and installed on units upgraded manufactured between 9/1/2004 through 11/20/2007; demonstrated a component life of approximately 2 years of simulated use. While the correct brake plates were installed on these beds; updated maintenance information was not included. Failure to maintain the bed brakes including th |
Stryker Medical Division of Stryker Corporation | Mar-30-2012 | Stryker Secure Care Bed (Model 3221 – Stryker Secure Model 3221; 230 V- 50/60 Hz; 500 lbs (227 Kg)Stryker; Kalamazoo; MI 49001Product Usage:Secure II (model 3221) Med/Surg beds are AlC powered hospital beds; intended for clinician use; which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The Secure II model is primarily used in the Med/Surg units; but may also be found in a Critical Care environment. . Models 3221 represents International Voltage configurations of the 3002 model. | The Brake Plate Body installed on Secure II and EPIC units since November 21st 2007; and installed on units upgraded manufactured between 9/1/2004 through 11/20/2007; demonstrated a component life of approximately 2 years of simulated use. While the correct brake plates were installed on these beds; updated maintenance information was not included. Failure to maintain the bed brakes including t |