Medical device recalls for May 2013

Class I recalls

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

Medtronic Neuromodulation     May-01-2013      Deep Brain Stimulation Lead Kit – Medtronic DBS Lead Kit for Deep Brain Stimulation; models 3387; 3387S; 3389; 3389S; 3391; 3391S.  Sterile and Non-Pyrogenic.Product Usage:  The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dystonia; Essential Tremor (ET); Obsessive-Compulsive Disorder (OCD); Parkinsons Disease (PD); and epilepsy.  There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits.  Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damag

Medtronic Neuromodulation     May-01-2013      Activa Dystonia Therapy Kit – Medtronic DBS Therapy for Dystonia Kit;  models 3317; 3319; 3337 and 3339.  Sterile and Non-Pyrogenic. Product Usage:Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic; intractable (drug refractory) primary dystonia; including generalized and/or segmental dystonia; hemidystonia; and cervical dystonia (torticollis).                There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia kits.  Medtronic has received reports of DBS leads being damaged at the connector end of the lead when the lead cap is used. The connector end of the lead is the end of the lead connected to the lead extension. Tightening or loosening of the setscrew may twist the setscrew connector block and may damag

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Shoulder Arthroscopy; Kit; Circulator – Presource PBDS; Shoulder Arthroscopy; Kit; Circulator    Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Shoulder Procedure; Kit; Circulator – Presource PBDS; Shoulder Procedure; Kit; Circulator       Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Total Hip; Kit; Circulator – Presource PBDS; Total Hip; Kit; Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Total Joint; Kit; Circulator – Presource PBDS; Total Joint; Kit; Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Total Knee; Kit; Circulator – Presource PBDS; Total Knee; Kit; Circulator                Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Beaufort Memorial Hospital; Anesthesia Circuit; Kit – Presource PBDS; Beaufort Memorial Hospital; Anesthesia Circuit; Kit               Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Knee Arthroscopy; Kit; Circulator – Presource PBDS; Knee Arthroscopy; Kit; Circulator           Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Hand; Kit; Circulator – Presource PBDS; Hand; Kit; Circulator        Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Extremity; Kit; Circulator – Presource PBDS; Extremity; Kit; Circulator               Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Knee Arthroscopy; Kit; Circulator – Presource PBDS; Knee Arthroscopy; Kit; Circulator           Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Major Abdominal; Kit; Circulator – Presource PBDS; Major Abdominal; Kit; Circulator             Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; General Laparoscopy; Kit; Circulator – Presource PBDS; General Laparoscopy; Kit; Circulator     Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS – A) Presource PBDS; Lap Chole; Kit; Clean Up; B) Presource PBDS; Greenwood LeFlore Hosp; Lap Chole; Kit              Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Cardinal Health; Medical Products & Services      May-03-2013      Presource PBDS; Gyn Laparoscopy Kit; Circulator – Presource PBDS; Gyn Laparoscopy Kit; Circulator               Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components; remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.

Abbott Diabetes Care; Inc.           May-09-2013      FreeStyle InsuLinx Blood Glucose Monitoring System – FreeStyle InsuLinx Blood Glucose Monitoring System:For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips.Abbott Diabetes Care; Inc.1360 South Loop RoadAlameda; CA 94502 USAThe FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.            AT rare; extremely high glucose levels (1024 mg/dL and above); the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.

Cook; Inc.            May-15-2013      Zilver PTX¿ Drug-Eluting Peripheral Stent – Zilver PTX Drug-Eluting Peripheral Stent; – 7 mm X 80mm; 125 cm; Rx; SterileProduct Usage:The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding; small metal; mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity.       Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-ElutingPeripheral Stent involving fractures of the delivery system inner catheter after stent deployment; and separation of theinner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events; including one death;occurred in cases where a tip separation

Cook; Inc.            May-15-2013      Zilver¿ PTX¿ Drug-Eluting Peripheral Stent – Zilver¿ PTX¿ Drug-Eluting Peripheral Stent – 6 mm X 80mm; 125 cm; Rx; SterileProduct Usage:The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding; small metal; mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps Preven the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to:  Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD .  improve blood flow to the extremity.       Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-ElutingPeripheral Stent involving fractures of the delivery system inner catheter after stent deployment; and separation of theinner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events; including one death;occurred in cases where a tip separation

Nephron Pharmaceuticals Corp.                May-29-2013      EZ Breathe Atomizer – EZ Breathe Atomizer  Model # EZ-100.For the delivery of liquid medications for respiratory usage.        Possible dislodgement of the "Plate A"; if this instance occurs; it presents a potential choking hazard.

Nephron Pharmaceuticals Corp.                May-29-2013      Asthmanefrin Starter Kit – Asthmanefrin Starter Kit contains ten (10) Asthmanefrin vials and one (1) EZ Breathe Atomizer.For the delivery of liquid medications for respiratory usage.                Possible dislodgement of the "Plate A"; if this instance occurs; it presents a potential choking hazard.

Nephron Pharmaceuticals Corp.                May-29-2013      EZ Breathe Medication Cup – EZ Breathe Medication Cup.For the delivery of liquid medications for respiratory usage.        Possible dislodgement of the "Plate A"; if this instance occurs; it presents a potential choking hazard.

Class II recalls

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

Date Posted       Recalling Manufacturer Trade Name/Product     Reason for Recall

May-01-2013      GE Healthcare; LLC          Optima MR430s MRI Scanner – Optima MR430s MRI Scanner; 5000-0002is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh); knee; ankle; foot; elbow; forearm; wrist; and hand.            Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

May-01-2013      GE Healthcare; LLC          MSK EXTREME MR SCANNER – MSK EXTREME MR SCANNER; MODEL AA5000The intended for use as a diagnostic imaging device to produce axial; sagittal; coronal and oblique images of the internal structures of the leg (excluding the thigh); knee; ankle; foot; forearm; elbow; wrist and hand.   Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

May-01-2013      Stryker Howmedica Osteonics Corp.       Howmedica Osteonics Corp. – Stryker Howmedica Osteonics Corp.  AxSOS  System Instrument.The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur; Proximal Humerus; Proximal Tibia; and the Distal Tibia. Per the operative technique; " A 4.3 mm Drill (REF 702743) is then used to drill the core hole for the locking screw. Using a fluoroscopy; check the correct depth of the drill; and measure the length of the screw. The Drill Sleeve should now be removed; and the correct length 5.0 mm Locking Screw is inserted using the Screwdriver T20 and Screw Holding Sleeve."                Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3;;X263mm; flat ; manufactured by Stryker Osteosynthesis; is incorrect.  The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.

May-01-2013      Owens & Minor Distribution; Inc.              MediChoice¿ Rayon Tipped OB/GYN Applicator – MediChoice¿ Rayon Tipped OB/GYN Applicator; 8 inch; Plastic Shaft; Non-Sterile; Item Numbers WOD5001 and WOD5002.Product Usage:  Usage:An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden; paper; or plastic stick. The device is used to apply medications to; or to take specimens from; a patient.                Owens & Minor Distribution; Inc. is conducting a market withdrawal of MediChoice Applicator OB-GYN 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use.

May-01-2013      GE Healthcare; LLC          Optima MR360/Brivo MR355 (HDsv); GE 0.35T Signa Ovation HD MR System; GE 0.2T Signa Profile HD MR Sy – GE Healthcare; Optima MR360/Brivo MR355 (HDsv); GE 0.35T Signa Ovation HD MR System; GE 0.2T Signa Profile HD MR System.Indicated for use as a diagnostic imaging device.      GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products.The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1; BRAVO T1; or CUBE T1) of over 126 slices may display a left-to-right image flip .In addition; the acquired sagittal images may be annotated with left-right location annotation revers

May-01-2013      GE Healthcare; LLC          Discovery MR750; Discovery 450; Optima 450W (with and without GEM); Signa HDx; Signa HDxt; Signa HDi – GE Healthcare; Discovery MR750; Discovery 450; Optima 450W (with and without GEM); Signa HDx; Signa HDxt; Signa HDi; Signa Vibrant.Indicated for use as a diagnostic imaging device.      GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products.The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1; BRAVO T1; or CUBE T1) of over 126 slices may display a left-to-right image flip .In addition; the acquired sagittal images may be annotated with left-right location annotation revers

May-01-2013      GE Healthcare; LLC          GE 1.5T SIGNA HDe MR SYSTEM – GE Healthcare; GE 1.5T SIGNA HDe MR SYSTEM.Indicated for use as a diagnostic imaging device.              GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products.The axial and coronal reformatted images from a sagittal 3D series (such as with applications of FSPGR-3D T1; BRAVO T1; or CUBE T1) of over 126 slices may display a left-to-right image flip .In addition; the acquired sagittal images may be annotated with left-right location annotation revers

May-02-2013      Trophy Sas          CareStream Dental – CareStream Dental CS 2100 X-ray systemProduct Usage:The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth; jaw and oral structures. There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.

May-02-2013      Trophy Sas          CareStream Dental – CareStream Dental CS 2200  X-ray systemProduct Usage:The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth; jaw and oral structures. There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.

May-02-2013      Trophy Sas          CareStream Dental – CareStream Dental Kodak 2200 Intraoral X-ray systemProduct Usage:The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth; jaw and oral structures.           There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.

May-02-2013      Trophy Sas          CareStream Dental – CareStream Dental Kodak 2100 Intraoral X-ray systemProduct Usage:The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth; jaw and oral structures.           There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator.

May-02-2013      Encore Medical; Lp          Tibial Insert – 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.               U.S. Agent contacted Director Commercial Logistics; notifying him of incorrect color coded labels on two packages of e+tibial inserts.  There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.

May-02-2013      NxStage Medical; Inc.    NxStage PureFlow-B Solution – NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401; packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.        Product may be mislabeled.

May-03-2013      Smiths Medical ASD; Inc.              Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet – Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with StyletPPS623Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure; the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure; the clinician places the outer sheath through the cervical canal into the uterus; then loads the embryo in the inner catheter; and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.    Unable to pass catheter through outer sheath during embryo transfer

May-03-2013      Smiths Medical ASD; Inc.              Wallace Sure-Pro¿ Two Stage Embryo Replacement  Catheter with Obturator – Wallace Sure-Pro¿ Two Stage Embryo Replacement  Catheter with ObturatorPPB623Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure; the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure; the clinician places the outer sheath through the cervical canal into the uterus; then loads the embryo in the inner catheter; and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.                Unable to pass catheter through outer sheath during embryo transfer

May-03-2013      Smiths Medical ASD; Inc.              Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet – Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with StyletProduct Code:PES623Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure; the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure; the clinician places the outer sheath through the cervical canal into the uterus; then loads the embryo in the inner catheter; and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.                Unable to pass catheter through outer sheath during embryo transfer

May-03-2013      Smiths Medical ASD; Inc.              Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator – Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with ObturatorProduct Code: PEB623Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure; the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure; the clinician places the outer sheath through the cervical canal into the uterus; then loads the embryo in the inner catheter; and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.                Unable to pass catheter through outer sheath during embryo transfer

May-03-2013      Smiths Medical ASD; Inc.              Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters – Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters  (with ultrasound)Product Code: PE623Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure; the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure; the clinician places the outer sheath through the cervical canal into the uterus; then loads the embryo in the inner catheter; and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.                Unable to pass catheter through outer sheath during embryo transfer

May-03-2013      Smiths Medical ASD; Inc.              Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter – Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Product Code: PP623Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure; the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure; the clinician places the outer sheath through the cervical canal into the uterus; then loads the embryo in the inner catheter; and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.       Unable to pass catheter through outer sheath during embryo transfer

May-03-2013      Synthes USA HQ; Inc.     Synthes Radial Head Prosthesis: Trial Radial Head – Synthes Radial Head Prosthesis: Trial Radial HeadElbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.            The Trial Head may come loose from the implant stem during manipulation of the arm during surgery.  To date; no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 32cm Aspiration Needle Tip.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.    The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:2mm X 32cm Regular Tip with 1 Hole; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.                The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:2mm X 32cm Regular Tip with 2 Hole; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.                The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:2mm X 34cm Regular Tip with No Hole; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.               The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 28cm Regular Tip; vented; Non-Reflective Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.               The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 32cm Regular Tip; vented; Non-Reflective Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.               The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:10mm X 32cm Regular Tip; vented; Non-Reflective Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.     The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 32cm Hydrodissection Tip; Non-Reflective Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.     The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 45cm Regular Tip; vented; Non-Reflective Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.               The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:Vented Tip; 5mm X 45cm Non-Reflective with 30¿ Downward Bend At Proximal End.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.         The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 32cm Regular Tip with No Holes; Non-Reflective Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.     The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:3mm X 32cm Regular Tip; Vented; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.                The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:3mm X 32cm Regular Tip; Non-Vented; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.               The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 24cm Regular Tip; Vented; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.                The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 32cm Regular Tip ; Non-Vented; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.               The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 45cm Regular Tip; Vented; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.                The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 32cm Tip Hydrodissection Tip; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.               The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:10mm X 32cm Pool Suction Tip; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.                The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 32cm Regular Tip; Vented; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.                The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-03-2013      Becton Dickinson & Co. BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack – BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack; REF 441124; contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton; Dickinson and Company 7 Loveton Circle; Sparks; MD 21152 USA www.bd.com/ds EC REP Benex Limited; Pottery Road; Dun Laoghaire; Co. Dublin; Ireland. Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.               Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.

May-03-2013      Stryker Endoscopy          Stryker Irrigator Reusable Tips – Stryker Irrigator Reusable Tips:5mm X 32cm Regular Tip; Vented; Metal Finish.Suction irrigator tips aid in cleaning and clearing the operative site during  laparoscopic surgery.                The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123?C ; instead of the correct 132-133?C.

May-07-2013      Baxter Healthcare Corp.                Non-DEHP Catheter Extension Set – A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set;  4.8"; Vol. 0.6 mL; Male Luer Lock Adapter; Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set; 5.7"; Vol. 0.7 mL; Male Luer Lock Adapter with Retractable Collar; Single use onlyProduct Usage:These devices are indicated for use with a vascular access device for administration and withdrawal of fluids.                Customers have reported that when separating an individual package from its attached grouping; the adjacent package has opened; compromising its sterile barrier properties.

May-07-2013      Baxter Healthcare Corp.                Non-DEHP Catheter Extension Set – A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set;  5.7"; Vol. 0.8 mL; 2 Injection Sites; Male Luer Lock Adapter; Single use only Product Usage:This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.       Customers have reported that when separating an individual package from its attached grouping; the adjacent package has opened; compromising its sterile barrier properties.

May-07-2013      Baxter Healthcare Corp.                Non-DEHP Catheter Extension Set – A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit; Single use only; includes: 1)  7.7"; Vol. 1.10 mL; Luer Activated Valve for IV Access; Male Luer Lock Adapter; 2) Medium Catheter Stabilization Device; and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Catheter Extension Set Kit; Single use only; includes: 1) 7.1"; Vol. 0.85 mL; Injection Site Male Luer Lock Adapter with Retractable Collar; 2) Medium Catheter Stabilization Device; and 3) Foam Tape Strips; C) Product Code 2N8222: Non-DEHP Catheter Extension Set Kit; Single use only; includes: 1) 8.2"; Vol. 0.57 mL; Luer Activated Valve for IV Access; Male Luer Lock Adapter; 2) Medium Catheter Stabilization Device; and 3) Foam Tape Strips; D) Product Code 2N8223: Non-DEHP Catheter Extension Set Kit; Single use only; includes: 1) 7.7"; Vol. 0.40 mL; Injection Site Male Luer Lock Adapter; 2) Medium Catheter Stabilization Device; and 3) Foam Tape Strips;E) Product Code 6N8220: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit; Single use only; includes: 1) 7.6"; Vol. 1.0 mL; Catheter Extension Set; Luer Activated Device with Silver for IV Access; Male Luer Lock Adapter with Retractable Collar; 2) Medium Catheter Stabilization Device; and 3) Foam Tape Strips; F) Product Code 6N8222: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit; Single use only; includes: 1) 8.2"; Vol. 0.5 mL; Catheter Extension Set; Luer Activated Device with Silver for IV Access; Male Luer Lock Adapter; 2) Medium Catheter Stabilization Device; and 3) Foam Tape StripsProduct Usage:The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids.         Customers have reported that when separating an individual package from its attached grouping; the adjacent package has opened; compromising its sterile barrier properties.

May-07-2013      Baxter Healthcare Corp.                Non-DEHP Catheter Extension Set – A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit; 6.0"; Vol. 1.0 mL; 2 Luer Activated Valves; Male Luer Lock Adapter; Single use onlyProduct Usage:The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids.            Customers have reported that when separating an individual package from its attached grouping; the adjacent package has opened; compromising its sterile barrier properties.

May-07-2013      Symmetry Medical/SSI  Codman(R) Collins Radioparent Sternal Blade Nylon – Codman(R) Collins Radioparent Sternal Blade Nylon;4 3/4" (121 mm) long;  3" (76 mm) wide; 1 1/2" (38 mm) deep; REF 50-8081sternum retractor              There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.

May-08-2013      Olympus America Inc.    Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") – Olympus SurgMaster UES-40 electrosurgical unit ("UES-40")Product Usage:  Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology; gynecology; respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories; endoscopes (fiberscopes; videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation); light sources and other ancillary equipment.       Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010.  The upgrade and enhancement were initiated due to complaints of overheating; smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit; model UES-40 ("UES-40") when used in conjunction with the Olympus WA22557C electrode.  The complaint investigations revealed that

May-08-2013      Siemens Healthcare Diagnostics; Inc.      Siemens Healthcare Diagnostices Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. – Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels..MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.       Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.

May-08-2013      Cypress Medical Products LLC    MediChoice Umbilical cord clamp – Cypress Medical Products LLC;  MediChoice Umbilical cord clamp; sterile; single use;  Distributed by Owens & Minor; Mechanicsville; VA.  The product is used to clamp the umbilical cord after childbirth.               Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord Clamps because recent complaints indicate the clamps are breaking upon use. The product may not perform as intended.

May-08-2013      Karl Storz Endoscopy America Inc             Karl Storz Photodynamic Diagnosis (PDD) D-Light C System; – KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System;Instruction Manuals:  PDD Telescopes; Tricam SL II; and PDD Camera Heads.Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.   The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes.

May-08-2013      Medshape Solutions; INC.           ExoShape Soft Tissue Fastener 12 mm x 30 mm – ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230.For use in the fixation of ligaments; tendons or soft tissue grafts to bone.                Expiration date on the patient label and date on the product carton were not the same.

May-09-2013      DePuy Mitek; Inc.; a Johnson & Johnson Co.       DePuy Mitek Tissue Liberator -Blade Up – DePuy Mitek Tissue Liberator -Blade UpCatalog Number:  214623The Reusable Arthroscopy Instruments are reusable; non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.        Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.

May-10-2013      American Medical Systems; Inc.                AMS 800¿ Urinary Control System – AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable; fluid filled; solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff; a pump; and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.     American Medical Systems; Inc. is initiating a recall on two components of the AMS 800? Urinary Control System;  Control Pump &  Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.

May-10-2013      American Medical Systems; Inc.                AMS 800¿ Urinary Control System. – AMS 800¿ Urinary Control System.  The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable; fluid filled; solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff; a pump; and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.     American Medical Systems; Inc. is initiating a recall on two components of the AMS 800? Urinary Control System;  Control Pump &  Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.

May-10-2013      Integra LifeSciences Corporation              DuraGen Plus Dural Regeneration Matrix – DuraGen Plus Dural Regeneration MatrixDuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle; soft; white pliable; non-friable; porous; collagen matrix. DuraGen Plus matrix is supplied sterile; nonpyrogenic; for single use in double peel packages in a variety of sizes.            Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              DuraGen XS Dural Regeneration Matrix – DuraGen XS Dural Regeneration MatrixDuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle; soft; white; pliable; non-friable; porous collagen matrix. DuraGen XS is supplied sterile; non-pyrogenic; for single use in double peel packages in a variety of sizes.     Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              NeuraWrap Nerve Protector – NeuraWrap Nerve ProtectorNeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.               Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              NeuraGen Nerve Guide – NeuraGen Nerve GuideNeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.           Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              INSTAT – INSTAT – Agent; Absorbable Hemostatic; Collagen BasedINSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.  Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              Helistat¿ Absorbable Hemostatic;Collagen Based – Helistat Absorbable Hemostatic;Collagen BasedHelistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.             Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              Helitene¿ Absorbable Collagen Hemostatic Sponge – Helitene Absorbable Collagen Hemostatic SpongeHelitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.             Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              CollaTape¿ Absorbable Collagen Wound Dressing for Dental Surgery – Colla Tape Absorbable Collagen Wound Dressing for Dental SurgeryThe Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.                Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              CollaCote¿ Absorbable Collagen Wound Dressing for Dental Surgery – CollaCote Absorbable Collagen Wound Dressing for Dental SurgeryThe Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.                Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              CollaPlug¿ Absorbable Collagen Wound Dressing for Dental Surgery – CollaPlug Absorbable Collagen Wound Dressing for Dental SurgeryThe Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.                Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              HeliTape¿ Absorbable Collagen Wound Dressing for Dental Surgery – HeliTape Absorbable Collagen Wound Dressing for Dental SurgeryThe Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.                Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              HeliPlug¿ Absorbable Collagen Wound Dressing for Dental Surgery – HeliPlug Absorbable Collagen Wound Dressing for Dental SurgeryThe Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.                Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              OraTape¿ Absorbable Collagen Wound Dressing for Dental Surgery – OraTape Absorbable Collagen Wound Dressing for Dental SurgeryThe Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.                Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              OraPlug¿ Absorbable Collagen Wound Dressing for Dental Surgery – Ora Plug Absorbable Collagen Wound Dressing for Dental SurgeryThe Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.                Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              OraMem¿ Absorbable Collagen Membrane – OraMem Absorbable Collagen MembraneOraMem¿ Absorbable Collagen Membrane is an absorbable; implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.   Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              BioMend¿ Extend" Absorbable Collagen Membrane – BioMend¿ Extend" Absorbable Collagen MembraneBioMend¿ Extend" Absorbable Collagen Membrane is an absorbable; implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.  Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              Layershield¿ Adhesion Barrier Matrix – Layershield Adhesion Barrier MatrixLayershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis.             Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Insight Instruments; Inc.               Insight Instruments MIS ( Multi-Port Illumination System) – Insight Instruments MIS ( Multi-Port Illumination System)  Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems.              Insight Instruments; Inc.; Stuart; FL is recalling M.I.S. (Multi-Port Illumination System); Ophthalmic Cannula due to a misclassification of the medical device.

May-10-2013      Integra LifeSciences Corporation              BioMend Absorbable Collagen Membrane – BioMend Absorbable Collagen MembraneBioMend¿ Absorbable Collagen Membrane is an absorbable; implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.   Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              Absorbable Collagen Sponge – Absorbable Collagen SpongeProvided As Intermediate to Another Company Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              DuraGen¿ Graft Matrix – Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle; soft; white; pliable; nonfriable; porous collagen matrix. DuraGen matrix is supplied sterile; nonpyrogenic; for single use in double peel packages in a variety of sizes..       Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-10-2013      Integra LifeSciences Corporation              DuraGen¿ Suturable DuraGen Dural Regenerative Matrix – Suturable DuraGen Dural Regenerative MatrixSuturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle; soft; white; pliable; nonfriable; porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile; non-pyrogenic; for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.      Due to the process deviation; product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz  Electrode; cutting – Electrode; cutting; 24FR (27050G/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).        Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz Electrode; cutting – Electrode; cutting; 24FR (27050G-.30/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).   Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz Electrode; Coag; Pointed – Electrode; Coag; Pointed; 24FR (27050L/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).         Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz Electrode; Coag; Ball End – Electrode; Coag; Ball End; 24FR (27050N/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).        Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz Electrode; Roller Ball – Electrode; Roller Ball; 24FR (27050NK/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).     Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz Loop; Cutting – Loop; Cutting; Angled 22FR (26055G/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).        Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz Electrode; Roller; Vaporization – Electrode; Roller; Vaporization; 24FR (27050RK/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).               Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz Electrode; VaporCut – Electrode; VaporCut; 24FR (27050SG/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).      Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz Loop; Cutting – Loop; Cutting; 24FR (26050G/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).        Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz Knife; Cold; Straight – Knife; Cold; Straight (27068K/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).         Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz Electrode; Cutting – Electrode; Cutting; 24FR; 0.30MM (27040G-.30/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).                Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-11-2013      Karl Storz Endoscopy America Inc             Karl Storz Electrode; Barrel Bar – Electrode; Barrel Bar; 24FR (27050NX/6).Resectoscope accessories (ie. electrode; cutting loops and cold knives).     Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products; which may result in airborne contamination.

May-13-2013      ConMed Corporation     PadPro(R) Adult Radiotransparent Multifunction Electrodes – PadPro(R) Adult Radiotransparent Multifunction Electrodes; REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing; defibrillation and monitoring applications        ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient.

May-14-2013      Heartware Inc   HVAD Pump Implant Kit – REF 1103***HVAD Pump Implant Kit.Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.          HeartWare; Inc. of Miami Lakes; FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.

May-14-2013      Edwards Lifesciences; LLC            Proplege Coronary Sinus Catheter – Proplege Coronary Sinus Catheter model PR9; 11 French Introducer; kitted with PR9.  Product Usage:  The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery.             Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter; model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter.

May-14-2013      GE Healthcare; LLC          GE Healthcare Innova 2100 IQ; Innova 3100 IQ; Innova 4100 IQ; Innova 2121 IQ; Innova 3131 IQ ; Innov – GE Healthcare Innova 2100 IQ; Innova 3100 IQ; Innova 4100 IQ; Innova 2121 IQ; Innova 3131 IQ ; Innova 3100; Innova 4100.For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures.       While performing a fluoroscopic examination on the GE Innova systems; there is a potential of nonrecoverableloss of imaging modes with no advance warning; due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date; there is riskof complications during the procedure as a result of imaging functionality loss.

May-14-2013      QIAGEN Gaithersburg; Inc.          Qiagen artus CMV RG PCR ASR (Analyte Specific Reagent) – QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage:  The artus CMV RG PCR ASR  is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time  PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).                CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.

May-14-2013      QIAGEN Gaithersburg; Inc.          Qiagen artus CMV RG PCR ASR – QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage:  Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA; as part of an in house validated real-time PCR assay.  One service package containing the handbook.  CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials.

May-14-2013      Summit Medical; Inc.      Summit Medical; BL-2006; Myringotomy Lance (Juvenile) Blade – Summit Medical; BL-2006; Myringotomy Lance (Juvenile) Blade; Sterile P; Summit Medical; Inc.; 815 Northwest Parkway; Suite 100; St. Paul; MN 55121Use to make an incision in the tympanic membrane.   Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile)  because the box contains the wrong blade. The box contains Myringotomy Spear Blade (Juvenile).

May-15-2013      Varian Medical Systems; Inc. Oncology Systems                Varian High Energy Clinacs – Varian High Energy Clinacs; High Energy Accelerator; Radiation Treatment System; Model Numbers: H14; H27;H29; HCX; Product Usage:The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions; tumors and conditions anywhere in the body when radiation treatment is indicated.      Varian has identified that under certain conditions; photon beams in High Energy Clinacs may experience a gradual change in beam symmetry; potentially reaching an asymmetry of up to approximately 7% before interlock occurs. At maximum asymmetry; this may result in no more than approximately 3.5% dose deviation from expected at any point in the beam; and may result in minor injury to the patient or

May-15-2013      Iris Diagnostics  Iris Diagnostics Division iQ Control/Focus Set – Iris Diagnostics Division iQ Control/Focus Set; Part Number 800-3104; Lot Number 153-12.Product Usage:  For in vitro diagnostic use with the iQ200 series.       The firm initiated this recall because complaints from customers reported that the recovery  compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.

May-15-2013      Varian Medical Systems; Inc.      Segmented Cylinder Applicator Set – Segmented Cylinder Applicator Set; Model # GM11004150; when used for Pulsed Dose Rate (PDR)Product Usage:  Usage:Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.              Segmented cylinder applicator set may slip during treatment; causing the delivery of radiation to areas outside the target.

May-16-2013      Becton Dickinson & Co. BBL Trypticase Soy Agar with 5% Sheep Blood – BBL(tm) Trypticase ™ Soy Agar with 5% Sheep Blood.Used for culturing microorganisms.             Microbiological media may be contaminated with bacteria.

May-16-2013      Becton Dickinson & Co. BBL CDC Anaerobe 5% Sheep Blood Agar. – BBL(tm) CDC Anaerobe 5% Sheep Blood Agar.Used for culturing microorganisms.               Microbiological media may be contaminated with bacteria.

May-16-2013      Becton Dickinson & Co. BBL Trypticase Soy Agar with 5% Sheep Blood and MacConkey II-I Plate – BBL(tm) Trypticase ™ Soy Agar with 5% Sheep Blood and MacConkey II-I Plate.Used for culturing microorganisms.                Microbiological media may be contaminated with bacteria.

May-16-2013      Medtox Diagnostics Inc PROFILE-V MEDTOXScan Drugs of Abuse Test System – PROFILE-V MEDTOXScan Drugs of Abuse Test System.For the rapid; qualitative detection of drugs of abuse in human urine;          Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.

May-17-2013      Johnson & Johnson Vision Care; Inc.       ACUVUE ADVANCE Brand Contact Lens – ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR; Soft; disposable contact lenses.The Vistakon (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less.          Limited number of individual contact lens packages may not have been completely sealed.

May-17-2013      Johnson & Johnson Vision Care; Inc.       1-DAy ACUVUE MOIST contact lens – 1-DAY ACUVUE MOIST Brand Contact Lenses; soft disposable contact lenses.The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens; Clear and Tinted (Visibility and/or Cosmetically); with UV Blocker for Daily Disposable Wear (spherical) is indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.       Limited number of individual contact lens packages may not have been completely sealed.

May-17-2013      Hologic; Inc.        Fluoroscan Mini C-arm InSight; software versions 1.x; 2.x; 3.x – Fluoroscan Mini C-arm InSight; software versions 1.x; 2.x; 3.xThe device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient; including but no limited to surgical orthopedic and podiatry use; critical and emergency procedures; and light anatomy imaging situation.             The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.

May-17-2013      Hologic; Inc.        Fluoroscan Mini C-arm InSight2; software versions 3.x; 4.0; 4.0.1; 4.0.2 – Fluoroscan Mini C-arm InSight2; software versions 3.x; 4.0; 4.0.1; 4.0.2The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient; including but no limited to surgical orthopedic and podiatry use; critical and emergency procedures; and light anatomy imaging situation.   The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.

May-20-2013      Coloplast Manufacturing US; LLC               Rostorelle L; Polypropylene Mesh – Rostorelle L; Polypropylene Mesh; Catalog number 501440; Manufacturer Coloplast A/S 3050 Denmark.         Coloplast is recalling one lot of  Restorelle L prosthesis because it is mislabeled.  The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.

May-20-2013      Boston Scientific CRM Corp         LATITUDE¿ Patient Management System – LATITUDE¿ Patient Management System; Model 6488; Version 7.3.The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.        Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because   between March 4 and 27; 2013; a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required; Patient non-compliance information that was intended.

May-20-2013      Philips Medical Systems (Cleveland) Inc Brilliance CT – Brilliance CT 16-Slice Water; System Code: 728245; Brilliance CT 10-Slice Water; System Code: 728250; Brilliance CT   6-Slice Water; System Code: 728255; MX8000 IDT 16; System Code: 728120 & MX8000 IDT 10; System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips Medical Systems (Cleveland); Inc.; 595 Miner Road; Cleveland; OH 44143Computed Tomography X-ray systems 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.    Philips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system; the calculations were too high.  Instead of storing the CTDIVol value for each slice in the DICOM tag; the system took the sum of all CTDIVol values from all the images in the dataset and stored this value in the DICOM tag; resulting in incorrect information.

May-20-2013      Linvatec Corp. dba ConMed Linvatec      HD Still Capture – Ref: VP1600 HD Still Capture System ConMed Linvatec .Captures; stores and transfers images generated by a medical endoscopic camera system during surgical procedures.       The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue.

May-21-2013      Chicago X-Ray Systems; Inc.        FONA  Blue X Imaging Srl – Fona Srl IntraOs 70 intra-oral x-ray systemIntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.           The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3.  Also; the user’s manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h).

May-21-2013      Roche Molecular Systems; Inc.  cobas 4800 – cobas¿ 4800 system z480 instrument.  Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.      In rare instances; channel shifted results have been generated with cobas? 4800 assays run on v1.1.1 of the cobas? 4800 system.  Raw data review indicates that; in these cases; all signals are shifted by one channel:channel 1 results report as channel 2;channel 2 results report as channel 3;channel 3 results report as channel 4; andchannel 4 results report as channel 1.In the reported

May-21-2013      Molift Inc.           Molift Smart SWL – Molift Smart SWL150 kg Product Usage:To lift and transport a patient in the horizontal or other required position from one place to another.      The Molift Smart (now known as the Molift Smart 150) is a foldable; mobile hoist with a safe working load ("SWL") of 150 kg (approximately 330 lbs.) and is intended for lifting and transferring a disabled person. The hoist is made out of lightweight materials for ease of operation.  It has castors and is battery-powered. The Molift Smart includes a leg spreading mechanism to give optimal functiona

May-21-2013      Molift Inc.           Molift Smart 150 – Molift Smart 150Product Usage:To lift and transport a patient in the horizontal or other required position from one place to another.              The Molift Smart 150 (formerly "Molift Smart") is a foldable; mobile; battery-powered hoist for lifting and transfer of disabled persons; with a safe working load ("SWL") of 150 kg (approximately 330 lbs.).  The hoist includes a leg-spreading mechanism; equipped with a safety mechanism; to give optimal safety and functionality to the device.

May-21-2013      Technidata S.A. TD-Synergy – TD-Synergy.Laboratory Information System.            Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request.

May-22-2013      DePuy Orthopaedics; Inc.             Pinnacle – Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner; Ref 1221-36-452Product Usage:An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.               DePuy Orthopaedics; Inc.  (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box.  The box was labeled for a 36IDX52OD +4 Neutral Liner; but the product enclosed was a 36IDX56OD Neutral Liner.  Three ( 3 ) complaints were received in January 2012.

May-22-2013      Medical Information Technology; Inc.     MEDITECH Bi-Directional LAB Analyzer Interface – MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH’s Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.      Incorrect transmission of laboratory results.

May-22-2013      Progressive Medical Inc                Progressive Medical Laparoscopic Electrode PTFE Coated L Hook – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – Laparoscopic Electrode PTFE Coated L Hook 33cm Length; Product number P0020; Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries          Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical NON-STICK CAUTERY TIP PTFE Coated Blade – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – NON-STICK CAUTERY TIP PTFE Coated Blade 2.50" (6.40) Length; Product number P0012; Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries     Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical Laparoscopic Electrode PTFE Coated Wire L Hook – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – Laparoscopic Electrode PTFE Coated Wire L Hook 33cm Length; Product number P0100 Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries     Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical Laparoscopic Electrode PTFE Coated L Hook – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – Laparoscopic Electrode PTFE Coated L Hook 44cm Length; Product number P0020X Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries  Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical NON-STICK CAUTERY TIP PTFE Modified Coated Blade – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – NON-STICK CAUTERY TIP PTFE Modified Coated Blade 2.50" (6.40cm) Length; Product number P0012M Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries   Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical Non-Stick Cautery Tip PTFE Coated Blade – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – NON-STICK CAUTERY TIP PTFE Coated Blade 6.5" (16.51cm) Length;  Product number P0014; Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128. Electrodes used in Electrosurgeries           Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical Non-Stick Cautery Tip PTFE Modified Coated Needle – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Length;  Product number P0013M; Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128. Electrodes used in Electrosurgeries    Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical Laparoscopic Electrode PTFE Coated Curved Blade – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length; Product number P0019 Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries     Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical NON-STICK CAUTERY TIP PTFE Modified Coated Blade – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY TIP PTFE Modified Coated Blade 6.5" (16.51cm) Length; Product number P0014M Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries   Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical Laparoscopic Electrode PTFE Coated Spatula – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – Laparoscopic Electrode PTFE Coated Spatula 33cm Length; Product number P0018 Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries          Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical Laparoscopic Electrode PTFE Coated Wire L Hook – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – Laparoscopic Electrode PTFE Coated Wire L Hook 44cm Length; Product number P0100X Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries     Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical Laparoscopic Electrode PTFE Coated Wire L Hook Split – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – Laparoscopic Electrode PTFE Coated Wire L Hook Split 33cm Length;Product number P0020S Rx Only.   Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries     Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical Laparoscopic Electrode PTFE Coated J Hook – Progressive Medical  PTFE Coated Disposable Electrosurgical Electrodes – Laparoscopic Electrode PTFE Coated J Hook 33cm Length; Product number P0021; Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries          Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical NON-STICK CAUTERY TIP PTFE Coated Needle – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – NON-STICK CAUTERY TIP PTFE Coated Needle 2.75" (6.99cm) Length; Product number P0013 Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries               Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical NON-STICK CAUTERY TIP PTFE Coated Sharp needle – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – NON-STICK CAUTERY TIP PTFE Coated Sharp Needle 2.00" (5.08cm) Length; Product number P0118 Rx Only. Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries   Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical Laparoscopic Electrode PTFE Coated J- Hook – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – Laparoscopic Electrode PTFE Coated J- Hook 44cm Length; Product number P0021X Rx Only.  Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Electrodes used in Electrosurgeries  Product coatings require 510K approval.

May-22-2013      Progressive Medical Inc                Progressive Medical Push Button Pencil With PTFE Blade and Holster – Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes – Push Button Pencil With PTFE Blade and Holster; Product number P0035H Sterilized by Radiation.  Manufactured for Progressive Medical; Inc.; St. Louis; MO 63128.  Rx OnlyElectrodes used in Electrosurgeries                Product coatings require 510K approval.

May-22-2013      Unimed Surgical Products; Inc.   PROGRESSIVE MEDICAL  Laparoscopic Electrode – PROGRESSIVE MEDICAL  Laparoscopic Electrode PTFE Coated L Hook 33cm.Intended for the cutting of soft tissue and coagulation.             Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.

May-23-2013      Separation Technology; Inc.        SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE – SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE.Produce a monolayer of cells onto a glass slide from any fluid suspension.      Separation Technology; Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to January 1; 2013 for having the potential to start up unexpectedly when encountering an electrostatic discharge.

May-23-2013      Stryker Howmedica Osteonics Corp.       Triathlon Femoral Distal Augment- Left – Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per packageHowmedica Osteonics Corp. 325 Corporate Drive; Mahwah; NJ 07430 USA Stryker France; ZAC Satolas Green Pusignan; Av de Satoles Green 69881Meyzieu; Cedex; FranceThis device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone              Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment.  In addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.

May-23-2013      Roche Diagnostics Operations; Inc.          Roche cobas e 602 module – Cobas¿ 8000 modular analyzer series software version 03-01; 02; 03 and 04; impacting the cobas e 602 module only.Product Usage:  Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules    When using the cobas e 602 module; Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met simultaneously: More than a total of 2000 reagent kits or diluents have been registered on the cobas e 602 modules within one system core; and two different diluent

May-23-2013      CEFLA DENTAL GROUP  MY Ray RXDC x-ray unit – MyRay RXDC dental unit x-ray unit        The RX DC dental x-ray unit was found to be noncompliant with  21CFR 1010;2; 1020.30(e) & 1020.30(h). Specifically; 1. The tube housing did not contain a Certification label.2. The collimator did not contain an identification label.3. The user’s manual did not contain leakage technique factors; tube housing cooling curves and rating charts; and technique factors which lead to operation at ma

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Diamond Needle; 4"; Part Number 2110-0506 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Diamond Needle; 4"; Part Number 2110-0506Product Usage:Facilitate placement of bone cement in weakened or diminished bone                There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Intel-GE Care Innovations LLC    QuietCare – QuietCare.Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.     Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Catheter; 8"; Part Number 2110-0526 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Catheter; 8"; Part Number 2110-0526Product Usage:Facilitate placement of bone cement in weakened or diminished bone               There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Beveled Needle; 4"; Part Number 2110-0505 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Beveled Needle; 4"; Part Number 2110-0505  Product Usage:Facilitate placement of bone cement in weakened or diminished bone                There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Syringe Delivery System; 6"; Part Number 2090-0504 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Syringe Delivery System; 6"; Part Number 2090-0504Product Usage:Facilitate placement of bone cement in weakened or diminished bone              There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Plunger Delivery System; 4"; Part Number 2090-501 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Plunger Delivery System; 4"; Part Number 2090-0501Product Usage:Facilitate placement of bone cement in weakened or diminished bone              There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Plunger Delivery System; 6"; Part Number 2090-0505 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Plunger Delivery System; 6"; Part Number 2090-0505Product Usage:Facilitate placement of bone cement in weakened or diminished bone              There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Plunger; 6"; Part Number 2110-0501 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Plunger; 6"; Part Number 2110-0501Product Usage:Facilitate placement of bone cement in weakened or diminished bone               There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Intel-GE Care Innovations LLC    QuietCare-Networked – QuietCare-Networked.Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.                Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Reamer; 8"; Part Number 2110-0525 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Reamer; 8"; Part Number 2110-0525Product Usage:Facilitate placement of bone cement in weakened or diminished bone               There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Reamer; 6"; Part Number 2110-0504 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Reamer; 6"; Part Number 2110-0504Product Usage:Facilitate placement of bone cement in weakened or diminished bone               There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         "Stryker Orthobiologics Aliquot Plunger; 8""; Part Number 2110-0502 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Plunger; 8""; Part Number 2110-0502            Product Usage:Facilitate placement of bone cement in weakened or diminished bone" There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Beveled Needle; 6"; Part Number 2110-0524 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Beveled Needle; 6"; Part Number 2110-0524Product Usage:Facilitate placement of bone cement in weakened or diminished bone                There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Catheter; 6"; Part Number 2110-0503 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Catheter; 6"; Part Number 2110-0503Product Usage:Facilitate placement of bone cement in weakened or diminished bone               There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Orthovita; Inc.; dBA Stryker Orthobiologics.         Stryker Orthobiologics Aliquot Plunger Delivery System; 4" ; Part Number 2090-502 – Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument – Aliquot Plunger Delivery System; 4"; Part Number 2090-0502Product Usage:Facilitate placement of bone cement in weakened or diminished bone              There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures.  This has been attributed to bending of the catheter during the retraction from the needle.  It was determined to be use errors.  The correction is limited to a revision of the Directions for Use.

May-24-2013      Beckman Coulter Inc.     Synchron LX system and UniCel DxC 600/800 System(s) Lactate Reagent – Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent; Part Number: A95550Product Usage:  Lactate (LACT) reagent; when used in conjunction with Synchron LX System(s); UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator; is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).    Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI); i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L.

May-24-2013      Zimmer; Inc.       Trabecular Metal" Tibia Stop Drill – NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia. Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result; there is a potential for the drill to not pass through the applicable drill guide.

May-24-2013      The Anspach Effort; Inc.                3mm Diamond Ball – ***REF S-3D*** 3mm Diamond Ball.Used for cutting and shaping bone.           Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

May-24-2013      Orthopedic Alliance LLC Zweimueller Type Stem SCS – Zweimueller Type Stem SCS-Standard Sz 01Zweimueller Type Stem SCS-Standard Sz 00Zweimueller Type Stem SCS-Standard Sz 1Zweimueller Type Stem SCS-Standard Sz 2Zweimueller Type Stem SCS-Standard Sz 3Zweimueller Type Stem SCS-Standard Sz 4Zweimueller Type Stem SCS-Standard Sz 5Zweimueller Type Stem SCS-Standard Sz 6Zweimueller Type Stem SCS-Standard Sz 7Zweimueller Type Stem SCS-Standard Sz 8Zweimueller Type Stem SCS-Standard Sz 9Zweimueller Type Stem SCS-Standard Sz 10Zweimueller Type Stem SCL-Lateralized Sz 3Zweimueller Type Stem SCL-Lateralized Sz 4Zweimueller Type Stem SCL-Lateralized Sz 5Zweimueller Type Stem SCL-Lateralized Sz 6Zweimueller Type Stem SCL-Lateralized Sz 7Zweimueller Type Stem SCL-Lateralized Sz 8Zweimueller Type Stem SCL-Lateralized Sz 9Zweimueller Type Stem SCR-Revision Sz 3Zweimueller Type Stem SCR-Revision Sz 4Zweimueller Type Stem SCR-Revision Sz 5Zweimueller Type Stem SCR-Revision Sz 6Zweimueller Type Stem SCR-Revision Sz 7Zweimueller Type Stem SCR-Revision Sz 8Zweimueller Type Stem SCR-Revision Sz 9Zweimueller Type Stem SCR-Revision Sz 10Zweimueller Type Stem SCR-Revision Sz 11Variety of hip and knee implants and instruments; multiple uses.         The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physicianand for every surgery.

May-24-2013      Orthopedic Alliance LLC Co-Cr cancellous bone screw – Co-Cr cancellous bone screw;15mmCo-Cr cancellous bone screw;20mmCo-Cr cancellous bone screw;25mmCo-Cr cancellous bone screw;30mmCo-Cr cancellous bone screw;35mmCo-Cr cancellous bone screw;40mmVariety of hip and knee implants and instruments; multiple uses.           The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physicianand for every surgery.

May-24-2013      Orthopedic Alliance LLC Bipolar Cap – Bipolar Cap; ID26mm; OD42mmBipolar Cap; ID28mm; OD44mmBipolar Cap; ID28mm; OD46mmBipolar Cap; ID28mm; OD48mmBipolar Cap; ID28mm; OD50mmBipolar Cap; ID28mm; OD52mmBipolar Cap; ID28mm; OD54mmBipolar Cap; ID28mm; OD56mm              The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physicianand for every surgery.

May-24-2013      Orthopedic Alliance LLC Femoral head – Femoral head; standard; ¿26mm; +0mmFemoral head;medium; ¿26mm;+3mmFemoral head; long; ¿26mm; +6mmFemoral head; X-long; ¿26mm; +9mmFemoral head; ¿28mm; -3mmFemoral head; ¿28mm; +0mmFemoral head; ¿28mm; +5mmFemoral head; ¿28mm; +10mmFemoral head; ¿32mm; -3mmFemoral head; ¿32mm; +0mmFemoral head; ¿32mm; +5mmFemoral head; ¿32mm; +10mmFemoral head; ¿36mm; -3mmFemoral head; ¿36mm; +0mmFemoral head; ¿36mm; +5mmFemoral head; ¿36mm; +10mmVariety of hip and knee implants and instruments; multiple uses.              The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physicianand for every surgery.

May-24-2013      Orthopedic Alliance LLC U2 Acetabular cup – U2 Acetabular cup; Ti beads porous coated; ¿44mmU2 Acetabular cup; Ti beads porous coated; ¿46mmU2 Acetabular cup; Ti beads porous coated; ¿48mmU2 Acetabular cup; Ti beads porous coated; ¿50mmU2 Acetabular cup; Ti beads porous coated; ¿52mmU2 Acetabular cup; Ti beads porous coated; ¿54mmU2 Acetabular cup; Ti beads porous coated; ¿56mmU2 Acetabular cup; Ti beads porous coated; ¿58mmU2 Acetabular cup; Ti beads porous coated; ¿60mmU2 Acetabular cup; Ti beads porous coated; ¿62mmU2 Acetabular cup liner assembly; 10¿hooded;44mmU2 Acetabular cup liner assembly; 10¿hooded;46mmU2 Acetabular cup liner assembly; 10¿hooded;48mmU2 Acetabular cup liner assembly; 10¿hooded;50mmU2 Acetabular cup liner assembly; 10¿hooded;52mmU2 Acetabular cup liner assembly; 10¿hooded;54mmU2 Acetabular cup liner assembly; 10¿hooded;56mmU2 Acetabular cup liner assembly; 10¿hooded;58mmU2 Acetabular cup liner assembly; 10¿hooded;60mmU2 Acetabular cup liner assembly; 10¿hooded;62mmVariety of hip and knee implants and instruments; multiple uses.    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physicianand for every surgery.

May-24-2013      Orthopedic Alliance LLC "UKNEE Patella – UKNEE Patella;small     2401-1010UKNEE Patella;medium                2401-1020UKNEE Patella;large    2401-1030UKNEE Patella;X-large               2401-1040UKNEE Onset Patella; 3 pegs; x-small      2403-1010 UKNEE Onset Patella; 3 pegs; small    2403-1020 UKNEE Onset Patella; 3 pegs; medium             2403-1030 UKNEE Onset Patella; 3 pegs; large          2403-1040 UKNEE Onset Patella; 3 pegs;X-large 2403-1050 Variety of hip and knee implants and instruments; multiple uses."            The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physicianand for every surgery.

May-24-2013      Orthopedic Alliance LLC "Tibial baseplate – Tibial baseplate;cemented;#1               2203-3010Tibial baseplate;cemented;#2               2203-3020Tibial baseplate;cemented;#3                2203-3030Tibial baseplate;cemented;#4                2203-3040Tibial baseplate; cemented; #5              2203-3050Tibial baseplate; cemented; #6              2203-3060Tibial insert;CR;plained;#1;9mm           2303-1211Tibial insert;CR;plained;#1;11mm         2303-1212Tibial insert;CR;plained;#1;13mm                2303-1213Tibial insert;CR;plained;#1;15mm         2303-1214Tibial insert;CR;plained;#1;18mm         2303-1215Tibial insert;CR;plained;#2;9mm           2303-1221Tibial insert;CR;plained;#2;11mm         2303-1222Tibial insert;CR;plained;#2;13mm                2303-1223Tibial insert;CR;plained;#2;15mm         2303-1224Tibial insert;CR;plained;#2;18mm         2303-1225Tibial insert;CR;plained;#3;9mm           2303-1231Tibial insert;CR;plained;#3;11mm         2303-1232Tibial insert;CR;plained;#3;13mm                2303-1233Tibial insert;CR;plained;#3;15mm         2303-1234Tibial insert;CR;plained;#3;18mm         2303-1235Tibial insert;CR;plained;#4;9mm           2303-1241Tibial insert;CR;plained;#4;11mm         2303-1242Tibial insert;CR;plained;#4;13mm                2303-1243Tibial insert;CR;plained;#4;15mm         2303-1244Tibial insert;CR;plained;#4;18mm         2303-1245Tibial insert;CR;plained;#5;9mm           2303-1251Tibial insert;CR;plained;#5;11mm         2303-1252Tibial insert;CR;plained;#5;13mm                2303-1253Tibial insert;CR;plained;#5;15mm         2303-1254Tibial insert;CR;plained;#5;18mm         2303-1255Tibial insert;CR;plained;#6;9mm           2303-1261Tibial insert;CR;plained;#6;11mm         2303-1262Tibial insert;CR;plained;#6;13mm                2303-1263Tibial insert;CR;plained;#6;15mm         2303-1264Tibial insert;CR;plained;#6;18mm         2303-1265Tibial insert; PS ; #1; 9mm        2303-3011Tibial insert; PS ; #1; 11mm      2303-3012Tibial insert; PS ; #1; 13mm      2303-3013Tibial insert; PS ; #1; 15mm      2303-3014Tibial insert; PS ; #1; 18mm      2303-3015Tibial insert; PS ; #2; 9mm        2303-3021Tibial insert; PS ; #2; 11mm      2303-3022Tibial insert; PS ; #2; 13mm      2303-3023Tibial insert; PS ; #2; 15mm      2303-3024Tibial insert; PS ; #2; 18mm      2303-3025Tibial insert; PS ; #3; 9mm        2303-3031Tibial insert; PS ; #3; 11mm      2303-3032Tibial insert; PS ; #3; 13mm      2303-3033Tibial insert; PS ; #3; 15mm      2303-3034Tibial insert; PS ; #3; 18mm      2303-3035Tibial insert; PS ; #4; 9mm        2303-3041Tibial insert; PS ; #4; 11mm      2303-3042Tibial insert; PS ; #4; 13mm      2303-3043Tibial insert; PS ; #4; 15mm      2303-3044Tibial insert; PS ; #4; 18mm      2303-3045Tibial insert; PS ; #5; 9mm        2303-3051Tibial insert; PS ; #5; 11mm      2303-3052Tibial insert; PS ; #5; 13mm      2303-3053Tibial insert; PS ; #5; 15mm      2303-3054Tibial insert; PS ; #5; 18mm      2303-3055Tibial insert; PS ; #6; 9mm        2303-3061Tibial insert; PS ; #6; 11mm      2303-3062Tibial insert; PS ; #6; 13mm      2303-3063Tibial insert; PS ; #6; 15mm      2303-3064Tibial insert; PS ; #6; 18mm      2303-3065Variety of hip and knee implants and instruments; multiple uses."                The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physicianand for every surgery.

May-24-2013      Orthopedic Alliance LLC Ball Head – Ball Head; 28 Short CERAMICBall Head; 28 Medium CERAMICBall Head; 28 Long CERAMICBall Head; 32 Short CERAMICBall Head; 32 Medium CERAMICBall Head; 32 Long CERAMICBall Head; 28 Short CoCrBall Head; 28 Medium CoCrBall Head; 28 Long CoCrBall Head; 28 X-Long CoCrBall Head; 28 XX-Long CoCrBall Head; 32 ShortBall Head; 32 MediumBall Head; 32 Long               The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physicianand for every surgery.

May-24-2013      Orthopedic Alliance LLC "Femoral component – Femoral component; CR; cemented; #1; left        2103-1310Femoral component; CR; cemented; #2; left              2103-1320Femoral component; CR; cemented; #3; left   2103-1330Femoral component; CR; cemented; #4; left              2103-1340Femoral component; CR; cemented; #5; left   2103-1350Femoral component; CR; cemented; #6; left              2103-1360Femoral component; CR; cemented; #1; right                2103-1410Femoral component; CR; cemented; #2; right                2103-1420Femoral component; CR; cemented; #3; right       2103-1430Femoral component; CR; cemented; #4; right                2103-1440Femoral component; CR; cemented; #5; right       2103-1450Femoral component; CR; cemented; #6; right                2103-1460Femoral component; PS; #1; left                2103-3110Femoral component; PS; #2; left          2103-3120Femoral component; PS; #3; left          2103-3130Femoral component; PS; #4; left                2103-3140Femoral component; PS; #5; left          2103-3150Femoral component; PS; #6; left                2103-3160Femoral component;PS; #1; right         2103-3210Femoral component;PS; #2; right         2103-3220Femoral component;PS; #3; right               2103-3230Femoral component;PS; #4; right         2103-3240Femoral component;PS; #5; right                2103-3250Femoral component;PS; #6; right         2103-3260Variety of hip and knee implants and instruments; multiple uses."  The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physicianand for every surgery.

May-25-2013      Alere San Diego; Inc.      Alere hCG Combo Cassette (20/10 mIU/mL) KIt – Alere" hCG Combo Cassette (20/10 mIU/mL) Kit.Product Usage:  The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine; as an aid in the early detection of pregnancy. It is for healthcare professionals only.   The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215; lots hCG1110133 and hCG1110135; because an investigation has indicated a portion of these Alere" hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere" hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere" hCG Cassette (20 mIU/mL) Product Insert contains information for

May-25-2013      Elekta; Inc.          Multileaf Collimator – Integrity 3.0Product Usage:The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. Unexpected movement during beam delivery may not be detected if there are incorrect static tolerances for Linac Geometric Axes loaded in Integrity R3.0.

May-25-2013      Canon Inc.           Full Auto Ref-Keratometer – Canon Full Auto Ref-Keratometer RK-F2; Catalog Number 6937B002AA.Product Usage:  This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.      Canon Inc. had received 17 claims from our foreignsales companies between October to November2012 that measurement value of RK-F2s refractivepower (SPH value) sometimes indicated abnormalvalue which occurs approximately 5% in probability.

May-25-2013      Angiodynamics; Inc.        AngioDynamics VenaCure EVLT Procedure Kits – AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit; Catalog Number: 11403301;  2)  Gold-Tipped Fiber 65cm Kit; Catalog Number: 11403302; 3)  Gold-Tipped Fiber 90cm Kit; Catalog Number: 11403304.Product Usage:This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.      AngioDynamics Inc.; is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits; because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the wrong French size.

May-25-2013      Alpine Biomed Aps          Natus neurology Dantec KEYPOINT – Natus neurology Dantec KEYPOINT.NET 2.20.Catalog/Part Numbers:9031A070103; 9031A006502; 9033A071103; 9033A072102; 9031A070102;9033A007402; 9033A071102; 9033A072103; 9033A0701; 9033A0711HA;9033A071101; 9031A070101; 9031A006401; 9031A006501; 9033A004701;9031A0032; 9033A0517; 9033A072101; 9031A0031; 9031A0701BV;9033A0044; 9033A0073AA; 9031A0063; 9033A0523; 9033A071143;9033A072143; 9031A006406; 9031A006506; 9031A070106; 9033A0046069033A004706; 9033A007406; 9033A0537; 9033A0544; 9033A071106;9033A072106; 9033A0524; 9033A0711BV; 9033A007401; 9033A0516;9031A006403; 9031A006503; 9033A056403; 9033A0721BV; 9031A006402;9031A006405; 9031A051306; 9031A070105; 9033A0072; 9033A007301;9033A0711AA; 9033A0721AAProduct Usage:Dantec KEYPOINT.NET Software 2.20 is installed on the Keypoint EMG System which is intended as an electro-physiological aid to assess diagnosis and prognosis and to monitor diseases of the central and peripheral nervous system. It can also be used to study functional aspects of nerves and muscles.                Alpine Biomed ApS is recalling Natus neurology Dantec KEYPOINT.NET ver. 2.20 Software due to the presence of a software bug.

May-25-2013      Angiodynamics; Inc.        AngioDynamics Micro Introducer Kits – AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit; Sterile; Catalog Number: 06597005; 2) AngioDynamics 5F Standard Micro-Introducer Kit; Sterile;   Catalog number: 06597012; 3) AngioDynamics 4F Standard Micro-Introducer Kit; Sterile; Catalog Number: 06597013; 4) AngioDynamics 5F Standard Micro- Introducer Kit; Sterile; Catalog Number: 06597018;  and 5) AngioDynamics 4F Standard Micro-Introducer Kit; Sterile; Catalog Number: 06597019.  Product kits are individually wrapped in plastic; 10 units included per box.Product Usage:This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.    AngioDynamics Inc.; is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits; because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size.

May-25-2013      Merit Medical Systems; Inc.        Performa¿ Cardiac Multipack – Merit Medical PerfOrma Anglographic Catheter 5F MultipackProduct Usage:Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.                Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.

May-25-2013      Polymer Technology Systems; Inc.           PTS Panels(R) Glucose Test Strips – PTS PANELS; Glucose Test Strips for use with CardioChek Brand AnalyzersProduct Usage:  used by healthcare professionals and individuals with diabetes to measure glucose in whole blood               Internal investigation demonstrated under-recovery for glucose when tested against a reference method.  This could result in a low to moderate health risk.

May-27-2013      Spinal Solutions; LLC       PEDICLE SCREW SYSTEM – 45 mm Screw; Item #BG7045Product Usage:Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.              The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

May-27-2013      Spinal Solutions; LLC       PEDICLE SCREW SYSTEM – 50 mm Screw; Item #BG7050Product Usage:Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.              The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

May-27-2013      Spinal Solutions; LLC       PEDICLE SCREW SYSTEM – Set Screw; Item #BG3010Product Usage:Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.                The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

May-27-2013      Spinal Solutions; LLC       PEDICLE SCREW SYSTEM – 40 mm Rod; Item #BG1640Product Usage:Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.                The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

May-27-2013      Spinal Solutions; LLC       "SPINE BUTTRESS (FANG) PLATE SYSTEM – Fang Screw 20mm      Fang Plate 21mmProduct Usage:Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple."    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

May-27-2013      Spinal Solutions; LLC       PEDICLE SCREW SYSTEM – 60 mm Rod; Item #BG1660Product Usage:Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.                The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

May-27-2013      Spinal Solutions; LLC       "PEDICLE SCREW SYSTEM – 12mm x 27mm x 8mm             12mm x 27mm x 9mm                12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mmProduct Usage:Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple."    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

May-27-2013      Spinal Solutions; LLC       "PEDICLE SCREW SYSTEM – 14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg        14 x 11 x 8mm 7 deg          14 x 11 x 9mm 7 deg        14 x 11 x 10mm 7 deg     14 x 11 x 11mm 7 deg     14 x 11 x 12mm 7 deg     Product Usage:Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple."  The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

May-27-2013      Spinal Solutions; LLC       "SPINE INTERBODY FUSION SYSTEM – Copperhead IBFD; Large Neutral; 6mm                Copperhead IBFD; Large Neutral; 7mm  Copperhead IBFD; Large Neutral; 8mm  Copperhead IBFD; Large Neutral; 9mm      Copperhead IBFD; Large Neutral; 10mm                Copperhead IBFD; Large Neutral; 11mmProduct Usage:Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple."            The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

May-27-2013      Spinal Solutions; LLC       PEDICLE SCREW SYSTEM – 50 mm Rod; Item #BG1650Product Usage:Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.                The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

May-28-2013      Alphatec Spine; Inc.        Leucadia Autolok" Polyaxial Pedicle Screw System – Leucadia Autolok" Polyaxial Pedicle Screw System.Intended to help provide correction; immobilization and stabilization of spinal segments.                Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing; the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs; the polyaxialscrew head and rod may fail to provide a rigid construct under loading. To date there have beenno reports of patient injury; adve

May-28-2013      RAYSEARCH LABORATORIES AB RayStation Therapy Treatment Planning System – RayStation Therapy Treatment Planning System; Model Numbers 2.0; 2.5; and 3.0; CLASSIFICATION NAME: System; Planning; Radiation Therapy Treatment.RayStation is a software system designed for treatment planning and analysis of radiation therapy.                Under some circumstances; imported CT; MR and PET images are offset from their true positions by one pixel in one or two directions.  Users must be aware of this information to avoid incorrect dose calculations during treatment planning.

May-29-2013      Intuitive Surgical; Inc.     8mm Maryland Bipolar Forceps – 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci S Surgical System; Model IS1200.Multiple use electrosurgical endoscopic instruments.                Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser;  preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.

May-29-2013      Intuitive Surgical; Inc.     8mm Precise Bipolar Forceps – 8mm Precise Bipolar Forceps used in conjunction with the da Vinci S Surgical System; Model IS1200.Multiple use electrosurgical endoscopic instruments. Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser;  preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.

May-29-2013      Intuitive Surgical; Inc.     8mm Fenestrated Bipolar Forceps – 8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci S Surgical System; Model IS1200.Multiple use electrosurgical endoscopic instruments.                Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser;  preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.

May-29-2013      Beckman Coulter Inc.     AU2700 and  AU5400 Clinical Chemistry Analyzers – AU2700 Clinical Chemistry AnalyzerAU5400 Clinical Chemistry AnalyzerPerform automated analysis of serum; urine; and other body fluids; including whole blood.     Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers becuase it was determined that the tubing/joint connections associated with these MODs may leak concentrated detergent. Beckman Coulter has received complaints that the joint connecting the tubing appears to disintegrate over time; causing a leak.

May-29-2013      Intuitive Surgical; Inc.     Flush Port – Flush Port (used in almost all da Vinci instruments)Assists in cleaning the instrument.                Clarification of existing labeling information and operating procedures.

May-29-2013      Intuitive Surgical; Inc.     da Vinci Si Surgeon Console – da Vinci Si Surgeon Console.Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.    Clarification of existing labeling information and operating procedures.

May-29-2013      Intuitive Surgical; Inc.     Cannula 8MM Regular – Cannula 8MM Regular.Provides the means of introduction and placement of an instrument or accessory into the human body.        Clarification of existing labeling information and operating procedures.

May-29-2013      Intuitive Surgical; Inc.     daVinci – User Manual  addendum; TORS for da Vinci Surgical System IS 1200; IS 2000 and IS 3000.Product Usage:The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.                Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.

May-29-2013      Becton Dickinson & Co. BBL DrySlide Oxidase kit – BBL DrySlide Oxidase Kit; catalog number 231746Product Usage:Presumptive diagnostic aid for gram-negative bacteria.   In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.

May-29-2013      Intuitive Surgical; Inc.     EndoWrist MCS Tip Cover Accessory – Tip Cover Accessory; 8 MM; MCS; box of 10Product Usage:The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.                Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.

May-29-2013      Intuitive Surgical; Inc.     daVinci TORS Indication of Use – Thyroidectomy Indication for the da Vinci Surgical Systems;Product Usage:da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures; including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.               Promotional literature for use of the da Vinci system for thyroidectomy; which had not been approved with a change to the 510(k).

May-29-2013      Becton Dickinson & Co. BBL DrySlide PYR kit – BBL DrySlide PYR Kit; catalog number 231747Product Usage:Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.     In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.

May-30-2013      Heart Sync; Inc  Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes – Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodesUsed in connection with a defibrillator to deliver an electrical current (shock) to the patient’s heart during cardiac emergencies.       On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.

May-30-2013      Heart Sync; Inc  Vermed; Inc Radiotransparent Defibrillation Electrodes – Vermed; Inc Radiotransparent Defibrillation ElectrodesMonophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes.Used in connection with a defibrillator to deliver an electrical current (shock) to the patient’s heart during cardiac emergencies.     On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.

May-30-2013      TZ Medical Inc.  Medtronic/Physio Control Transparent Defibrillation Electrodes – adult defibrillation; cardioversion; pacing; monitoring Disposable Electrodes; Model P-211-M1 and P-214-M1.Product Usage:Used by trained professionals in hospitals; doctors offices; and Emergency Medical Services for adult low-energy defibrillation; transcutaneous pacing; cardioversion and monitoring.   TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly.If a failure were to occur; the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the Gray Medtronic / Physio adapter. The consignees will notice discolor

May-30-2013      Fisher & Paykel Healthcare; Ltd.                Fisher & Paykel Healthcare ICON CPAP – Fisher & Paykel  Healthcare ICON CPAP (continuous positive airway pressure).Models:  ICON Auto:  ICONAAN; ICONAAN-HT; ICONAAJ.ICON Novo:  ICONNAN; ICONNAN-HT; ICONNAJ.ICON Premo:  ICONPBN; ICONPBN-HT; ICONPBN-HTC.The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.             Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP.  These ICON CPAP units could potentially become inoperable; which would result in a lack of treatment to the patient’s obstructive sleep apnea symptoms until a replacement unit is obtained.