Baylis Medical Corp * Nov-01-2013 TorFlex – Baylis Medical TorFlex Transseptal guide sleeve; accept only; pyrogen-free; sterile.Product use: TorFlex Transseptal Guide Sheath Kit (K102948) is a disposable device consisting of three components: sheath; dilator; and J-shaped tip guide wire.The kit is designed for safe and easy catheterization and angiography of specific ventricles and locations.The TorFlex transseptal guide sheath kit is being recalled because the sheath may remove particles smaller than 5 mm from the dilator.The particles may migrate into the patient’s blood.
Medtronic Vascular Nov-15-2013 Zinger¿Stainless steel main guide wire – Zinger¿Stainless steel main guide wire; Model: ZNGRLS180HJ; ZNGLRS180HS; ZNGRMS180HJ; ZNGRMS180HS; ZNGRMS180S; ZNGRS180HJ; ZNGRS180HS; ZNGRS180SMedtronic guide wire is a steerable guide wire used to introduce and place diagnostic or interventional devices in coronary arteries and peripheral vascular systems; and Can be used to reach and pass through target lesions.Medtronic guide wires are not suitable for use in the cerebrovascular system.Medtronic can be used to exchange guide wires to facilitate the replacement of one diagnostic or interventional device with another.The PTFE (polytetrafluoroethylene) coating may delaminate and separate from the guide wire.
Medtronic Vascular November 15, 2013 Cougar? Nitinol main guide wire – Cougar? Nitinol main guide wire: Model: CGRLS190HJ; CGRLS190HS; CGRLS190S; CGRLS300HS; CGRLS300S.CGRXT190HJ; CGRXT190HS; CGRXT190J; CGRXT190S; CGRXT300HJ; CGRXT300HS; CGRXT300J; CGRXT300SMedtronic guide wire is a steerable guide wire used to introduce and place diagnostic or interventional devices in the coronary arteries and peripheral vascular system; and can be used to reach and pass through target lesions .Medtronic guide wires are not suitable for use in the cerebrovascular system.Medtronic can be used to exchange guide wires to facilitate the replacement of one diagnostic or interventional device with another.The PTFE (polytetrafluoroethylene) coating may delaminate and separate from the guide wire.
Medtronic Vascular Nov-15-2013 THUNDER¿Steerable guide wire – THUNDER¿Additional support guide wire; Model: THNDR190J; THNDR190S; THNDR300J; THNDR300 SMedtronic guide wire is a steerable guide wire used to introduce and place diagnostic or interventional devices in the coronary artery and peripheral vascular system; and can be used to reach and pass through target lesions .Medtronic guide wires are not suitable for use in the cerebrovascular system.Medtronic can be used to exchange guide wires to facilitate the replacement of one diagnostic or interventional device with another.The PTFE (polytetrafluoroethylene) coating may delaminate and separate from the guide wire.
Medtronic Vascular Nov-15-2013 ProVia¿CROSSING GUIDEWIRE – ProVia¿CROSSING GUIDEWIRE; Model: 15PROV300HS; 3PROV180HS; 3PROV180SS; 3PROV300HS; 3PROV300SS Medtronic guide wire is a steerable guide wire used to introduce and place diagnostic or interventional devices in the coronary artery and peripheral vascular system; and can be used to reach and pass through the target lesion .Medtronic guide wires are not suitable for use in the cerebrovascular system.Medtronic can be used to exchange guide wires to facilitate the replacement of one diagnostic or interventional device with another.The PTFE (polytetrafluoroethylene) coating may delaminate and separate from the guide wire.The Medtronic guide wire is a steerable guide wire used to introduce and place diagnostic or interventional devices in the coronary arteries and peripheral vascular system; and can be used to reach and pass through target lesions.Medtronic guide wires are not suitable for use in the cerebrovascular system.Medt
Medtronic Vascular Nov-15-2013 ATTAIN HYBRID guidewire – ATTAIN HYBRID guidewire; Model: GWR419478; GWR419488; GWR419688 Attain Hybrid guidewire is designed to help place the Medtronic transvenous left ventricular lead in the coronary vasculature.The PTFE (polytetrafluoroethylene) coating may delaminate and separate from the guide wire.
Medtronic Vascular Nov-15-2013 COUGAR¿Steerable guide wire – COUGAR¿Steerable guide wire; Model: LVCLS190J; LVCLS190S; LVCXT190J; LVCXT190 SMedtronic guide wire is a steerable guide wire used to introduce and place diagnostic or interventional devices in the coronary arteries and peripheral vascular system; and can be used to reach and pass through target lesions .Medtronic guide wires are not suitable for use in the cerebrovascular system.Medtronic’s steerable exchange guide wire is used to promote the potential of replacing one diagnostic or interventional device with another PTFE (polytetrafluoroethylene) coating to delaminate and separate the guide wire.
Medtronic Vascular Nov-15-2013 THUNDER¿Turnable guide wire – THUNDER¿Steerable guide wire; Model: LVTNDR190SMedtronic guide wire is a steerable guide wire used to introduce and place diagnostic or interventional devices in the coronary arteries and peripheral vascular system; and can be used to reach and pass through target lesions.Medtronic guide wires are not suitable for use in the cerebrovascular system.Medtronic can be used to exchange guide wires to facilitate the replacement of one diagnostic or interventional device with another.The PTFE (polytetrafluoroethylene) coating may delaminate and separate from the guide wire.
Medtronic Vascular November 15, 2013 ZINGER Swivel Guide Wire – ZINGER Swivel Guide Wire; Model: LVZRLS180J; LVZRLS180S; LVZRMS180J; LVZRMS180S; LVZRXT180J; LVZRXT180J; LVZRXT180 SMedtronic guide wire is a steerable guide wire for use in coronary arteries and peripheral blood vessels The system introduces and places diagnostic or interventional equipment; and can be used to reach and pass through target lesions.Medtronic guide wires are not suitable for use in the cerebrovascular system.Medtronic can be used to exchange guide wires to facilitate the replacement of one diagnostic or interventional device with another.The PTFE (polytetrafluoroethylene) coating may delaminate and separate from the guide wire.
Del Mar Reynolds Medical Company; Ltd. Nov-20-2013 BleaseSirius Anesthesia Workstation; BleaseFocus Anesthesia Workstation-CAS I/II Absorber as part of BleaseSirius Anesthesia Workstation; BleaseFocus Anesthesia Workstation, part numbers are as follows: 12200900; 12200901; 12200902; 12200903; 14200100; and repair kit part numbers 050-0659-00 and 050-0901-00.BleaseFocus anesthesia workstation: Blease Frontline Plus series; anesthesia machine is designed to be used in hospital environments and places where portability is not required.It can be used to deliver oxygen; with or without a mechanical ventilator, air and nitrous oxide are delivered to various patient breathing circuits in a controlled manner; and it can be used to deliver anesthetic vapor by using a detachable vaporizer.This device is for use by doctors with appropriate qualifications only.BleaseSirius Anesthesia Workstation: Spacelabs BleaseSirius Anesthesia Workstation is designed for use in hospital environments and operating rooms.It can be used to deliver oxygen; with or without a mechanical ventilator, air and nitrous oxide are delivered to various patient breathing circuits in a controlled manner; and it can be used to deliver anesthetic vapor by using a detachable vaporizer.This device is only for use by doctors with appropriate qualifications.Recall by Spacelabs Healthcare Ltd., UK; and service pack; part numbers 050-0659-00 and 050-0901-00.The Bag to-Vent switch in the CAS I/II absorber may malfunction due to loose fastening hardware in the absorber.
Hospira Inc. November 21, 2013 Gemstar Infusion System – GemStar pump is small and lightweight; a single-channel infusion device designed for home use; in a hospital; or any place where electronic infusion is required.The GemStar pump can be powered by an AC power adapter; a rechargeable battery pack; a docking station; or two disposable AA alkaline batteries.When powered by a battery; the GemStar pump is ideal for ambulatory patients.The calibration of the proximal and distal pressure sensors may drift, causing the pump to fail the proximal or distal occlusion operation test; as described in the GemStar technical service manual; or report one of the following errors during device setup or infusion: 1 ) Cassette Check-D; 2) Tape check-P; 3) Proximal occlusion; 4) Distal occlusion; 5) Pressure calibration error
Hospira Inc. November 21, 2013 Gemstar Infusion System – GemStar pump is small and lightweight; a single-channel infusion device designed for home use; in a hospital; or any place where electronic infusion is required.The GemStar pump can be powered by an AC power adapter; a rechargeable battery pack; a docking station; or two disposable AA alkaline batteries.When powered by a battery; the GemStar pump is ideal for ambulatory patients.The calibration of the proximal and distal pressure sensors may drift, causing the pump to fail the proximal or distal occlusion operation test; as described in the GemStar technical service manual; or report one of the following errors during device setup or infusion: 1 ) Cassette Check-D; 2) Tape check-P; 3) Proximal occlusion; 4) Distal occlusion; 5) Pressure calibration error
Siemens Medical Solutions United States; Inc November 1, 2013 Siemens RAD fluorourethral system-Siemens RAD fluorourethral system-Luminos dRF; Ysio and Uroskop Omnia, software versions are VB10D; VB10F; VB10C and VB10E.Fluroscopic X-Ray Systems Siemens found latent failures in the system running with the VB10D software version through product monitoring; VB10F; VB10C and VB10.During the RAD inspection, there is a possibility that the radiation duration may be longer than expected, and may cause unnecessary doses to be applied during the collection process.In addition; the user cannot stop the radiation manually; hehe
Smith & Nephew Inc November 1, 2013 GENESIS(R) II; non-porous tibial base; size 6; right-GENESIS(R) II; non-porous tibial base; size 6; pair; quantity: (1); REF 71420188 Product use: orthopedic exchange products.The non-porous tibial base of size 5 L was incorrectly packaged as size 6 R, and vice versa.
Smith & Nephew Inc November 1, 2013 GENESIS(R) II; non-porous tibial base; size 5; left-GENESIS(R) II; non-porous tibial base; size 5; remaining; quantity: (1); REF 71420168. Product use: orthopedic exchange products.The non-porous tibial base of size 5 L was incorrectly packaged as size 6 R, and vice versa.
Edwards Life Sciences; LLC November 1, 2013 Edwards Duraflo Coated Dispersive Tip Arterial Cannula-Edwards Lifesciences Dispersive Aortic Perfusion Cannula with Duraflo Coating; Sterile; RX only for single use only; product use : Aortic perfusion cannula is used to perfuse the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass surgery.Aortic cannulas with sizes from 6Fr to 18Fr can be used in the pediatric patient population.The extracorporeal circuit components with Duraflo coating are intended for cardiopulmonary surgery that requires heparin-coated blood pathways.Edwards Lifesciences is recalling two batches of Duraflo cannulas because of the reported complaints involving cracks in the T-connector of the device, which were confirmed during the product evaluation.
Edwards Life Sciences; LLC November 1, 2013 Duraflo coated Fem-Flex arterial cannula – Edwards Lifesciences Fem-Flex femoral artery cannula with Duraflo coating; DIITFA02225; sterile; RX only is for single use only; Product use: Edwards Lifesciences femoral access cannula is suitable for situations that require rapid femoral vein and arterial access for short-term (< 6 hours) extracorporeal circulation.The vascular access (venous or arterial) is at the discretion of the doctor.According to flow rate requirements and individual patient anatomy, femoral access cannula can be used for pediatric or adult population.Please refer to the label to determine the pressure drop associated with the flow rate.The extracorporeal circuit components with Duraflo coating are intended for cardiopulmonary surgery that requires heparin-coated blood pathways.Edwards Lifesciences is recalling two batches of Duraflo cannulas because of the reported complaints involving cracks in the T-connector of the device, which were confirmed during the product evaluation.
EKOS Corporation Nov-01-2013 EKOS EkoSonic control unit – EkoSonic endovascular system uses high frequency (2-2.5 MHz); low power (0.585 watts of average power per transducer) ultrasound helps to deliver in the peripheral vascular system The doctor specifies the fluid and delivers the solution to the pulmonary artery.The EkoSonic endovascular system is designed for the controlled and selective infusion of fluids specified by the doctor; including thrombolytics; entering the peripheral vasculature and injecting the solution into the pulmonary artery.The reusable EKOS EkoSonic control unit powers the system and the user interface controlled by the operator.A reusable; non-sterile connector interface cable connects the EKOS EkoSonic control unit to the EkoSonic endovascular device.The EkoSonic control unit was recalled because it was installed with the wrong power input module.It lacks AC filters to reduce noise and electrical interference.
Stryker Instruments Division Stryker Corporation November 1, 2013 Dekompressor percutaneous discectomy probe-Dekompressor percutaneous discectomy probe.Dekompressor is a disposable discectomy probe that is passed through and used in conjunction with the guide sleeve to remove the nucleus pulposus material of the intervertebral disc.Stryker has discovered that when Dekompressor is used in violation of the warnings in the Instructions for Use (IFU), the auger and/or casing may break.Specifically; manually bending the cannula will weaken the device and may cause the auger and/or the cannula to break.This may result in the need for additional medical intervention to remove the debris; pain or loss of m
Beckman Coulter Inc. Nov-01-2013 Coulter LH 750 Hematology Analyzer Coulter LH 780 Hematology Analyzer – COULTER LH 750 and LH 780 Analyzer.The COULTER LH 750 hematology analyzer is quantitative; an automatic hematology analyzer and white blood cell sorting counter for in vitro diagnostics in clinical laboratories.The COULTER LH 750 hematology analyzer provides automatic reticulocyte analysis and nucleated red blood cell (NRBC) counting as well as automatic methods for counting RBC and WBC in body fluids.COULTER LH 780 hematology analyzer is a quantitative; automatic hematology analyzer and white blood cell sorting counter for in vitro diagnosis in clinical laboratories.The COULTER LH 780 hematology analyzer also provides automatic reticulocyte analysis and nucleated red blood cell (NRBC) counting, as well as automated methods for counting RBC and WBC in body fluids.Beckman Coulter began to recall Coulter LH 750 hematology analyzer (PN 6605632 and A85570) and Coulter LH 780 hematology analyzer (PN 723585 and A90728)
Carestream Health Inc. November 1, 2013 DRX Revolution Mobile X-ray System-DRX Revolution; catalog number 1) 1019397; 2) 1023415 (with installation warranty; US only) and 3) 1023423 (with parts warranty; US only) ).The device is designed to perform X-ray examinations on all children and adult patients; in all patient treatment areas, Carestream Health Inc. is recalling the column end caps due to the DRX Revolution mobile X-ray system falling off the column.
Zimmer; Co., Ltd. 10 of the trauma system are used with Ti-Versa-Fx? II femoral fixation system lag screws for internal fixation of proximal femur and supracondylar fractures.Ti-Magna Fx system is a kind of bone products used in orthopedic surgery, used for open internal fixation of femoral neck fractures; condyles; or tibia; etc.The washer prevents the screw head from being buried in the bone.Zimmer recently reviewed the completed historical packaging verification.Based on this review; it has been determined that a subset of products packaged in a single Zimmer plant needs to be tested to ensure that the products previously packaged in that plant meet the established requirements for the integrity of the sterile barrier.The number of samples required for packaging testing; provide statistics
Bayer Healthcare Llc Nov-03 Manufactured and distributed by LLC; Sunnywell; CA A1CNow+ test quantitatively measures the percentage of glycosylated hemoglobin (%HbA1c or %A1C) levels in capillary (fingertips) or venous whole blood samples.This test is used for professional purposes to monitor the blood sugar control of diabetic patients.When the product is stored at room temperature four (4) to five (5) months after release, the test results of these batches may produce highly biased readings (up to 20%), beyond those defined for stability and product accuracy limit.
Elekta; Inc. November 4, 2013 Stereotactic circular collimator – 3D line stereotactic hardware accessories – Stereotactic ring collimator – 3D line stereotactic hardware accessories This equipment is a medical device category used for radiotherapy Part of it is used to treat head tumors.The possibility of clinical error.
Intuitive surgery; Inc. Nov-04-2013 Patient cart used in conjunction with da Vinci S surgery and SI system-Patient cart used in conjunction with da Vinci S surgery and SI system.Intuitive Surgical1266 Kifer RoadSunnyvale; CA 94086 Patient Side Cart (PSC) is a robotic platform for Da Vinci surgery.It is the operating part of the Da Vinci system, and its main function is to support the instrument arm and camera arm.It uses remote center technology.The remote center is a fixed point in the space around which the patient cart arm moves.The remote center technology enables the system to manipulate instruments and endoscopes at the surgical site while applying minimal force to the patient’s body wall.The patient cart works in the sterile field; assists the surgeon console operator by changing instruments and endoscopes; and by performing other patient activities.Help ensure patient safety; the operation of the patient cart operator takes precedence over the operation of the Surgeon Console operator.The number of complaints about patient cassettes where fluid enters the da Vinci S and SI systems has increased.
Beckman Coulter Inc. Nov-04-2013 UniCel DxH 800 and DxH 600 Coulter cell analysis system – UniCel DxH 800 and DxH 600 Coulter cell analysis system UniCel DxH 800/DxH 600 analyzer is quantitative; multi-parameter; for in vitro diagnostics Automated hematology analyzer for screening patient populations found in clinical laboratories.DxH 800 can be used as an analyzer for desktop or floor stand.DxH 600 can be used as an analyzer and can only be used on a desktop.Beckman Coulter is initiating a recall of UniCel DxH 800 Coulter Cell Analysis System (PN 629029) and UniCel DxH 600 Coulter Cell Analysis System (PN B23858) because internal investigations by the company indicate that specific batches of DxH 800 are used in multiple locations The check valve and DxH 600 system may malfunction.Failure may cause air or liquid leakage in the VCS waste treatment chamber
Richard Wolf Medical Instruments Corp. November 4, 2013 Bipolar Vaporized Electrode-Partially labeled single unit: REF: 4630022; for S(a) line resectoscope; vaporized electrode; cemented carbide; 4mm telescope 30 25/12 ：Only used for continuous flushing sheath 24; 5 Fr.; batch number 426111; 2011/06; 2016/06; sterile; Richard Wolfe; part of the carton marked with 3 units: REF 46300223; vaporized electrode ; Sterile; 4 mm telescope 30/25/12; only used for continuous irrigation sheath 24; 5 Fr.; Lot No. 426111; 2011/06; 2016/06; sterile; RICHARD WOLFS(a)line resectoscope For endoscope-controlled tissue resection (ablation), 0.9% NaCl solution (saline) is used as the irrigation medium.It can also be used for unipolar resection if necessary.Richard Wolf Medical Instrument Corporation received a complaint stating that the 4630024 vaporized electrode was packaged in a 4630022 bag.
Sorin Group Deutschland GmbH Nov-04-2013 Sorin S5 Perfusionn System – S5 heart-lung machine; Stockert S5 system.Catalog number: 48-30/40/50-00.The Stockert S5 system is designed for surgery that lasts six (6) hours or less during cardiopulmonary bypass.Due to cardioplegia control failures, Sorin Group is recalling certain models of S5 perfusion systems.
Insight Instrument; Inc. November 4, 2013 MLS Torpedo Mini-Light ophthalmic single-port lighting – MLS Torpedo Mini-Light ophthalmic single-port lighting.If necessary, seamless 25-gauge illuminator for vitreoretinal surgery when full-field illumination is required for two-handed surgery.The product was registered and distributed as a Class I medical device, and was subsequently determined as a Class II medical device that requires FDA market approval.
Medtronic Vascular; Inc. Nov-05-2013 Resolute Integrity Zotarolimus-eluting Coronary Stent – Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; stent length 34 mm; receiving; Sterile.Mfg in Medtronic, Ireland; Galaway; Ireland .Distribution: Medtronic, Minneapolis; MN. Used to improve the patient’s coronary artery lumen diameter.A small number of devices with Resolute Integrity Zotarolimus-Eluting Coronary Sten System batch number 0006573585 may contain a compliance chart that incorrectly quotes a 2.25 mm diameter instead of the correct 3.0 mm diameter.
Insulet Corporation Nov-05-2013 OmniPod Insulin Management System Starter Kit – OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: Starter Kit (SKT-UST400) is provided to users before starting care Introduction to Omnipod insulin management system.It includes Personal Diabetes Manager (PDM) with two AAA alkaline batteries; USB data cable; user guide; a soft carrying case; troubleshooting guide; warranty registration card; and two alcohol pads.The OmniPod insulin management system is designed to deliver insulin at a fixed and variable rate subcutaneously, used to manage diabetes in people who need insulin, and to quantitatively measure glucose in fresh whole capillary blood (in vitro) from fingers.Glucose measurements should not be used for the diagnosis or screening of diabetes.The PDM blood glucose meter is for single patient use only and should not be shared.Abbott FreeStyle test strips are used in conjunction with the built-in FreeStyle measuring instrument to quantitatively measure blood glucose in fresh capillary blood in fingers; upper arms and palms.Abbott Freestyle Control Solutions is used to verify whether the meter and test strips are working properly and whether the test is performed correctly.The alcohol preparation pad included in the kit is not properly labeled.
Insulet Corporation Nov-05-2013 OmniPod Insulin Management Product Demonstration Kit – OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: Demonstration Kit (PDK-ZXP490) is provided to potential patients by healthcare professionals Alternative kits, allowing patients to experience the feeling of wearing a Pod before purchasing.Each demo kit includes a UST400 manual; an alcohol pad; and a Pod.The OmniPod insulin management system is designed to deliver insulin at a fixed and variable rate subcutaneously, used to manage diabetes in people who need insulin, and to quantitatively measure glucose in fresh whole capillary blood (in vitro) from fingers.Glucose measurements should not be used for the diagnosis or screening of diabetes.The PDM blood glucose meter is for single patient use only and should not be shared.Abbott FreeStyle test strips are used in conjunction with the built-in FreeStyle measuring instrument to quantitatively measure blood glucose in fresh capillary blood in fingers; upper arms and palms.Abbott Freestyle Control Solutions is used to verify whether the meter and test strips are working properly and whether the test is performed correctly.The alcohol preparation pad included in the kit is not properly labeled.
Smith Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Tray – Portex¿Spinal Tray Medicine 25g Whitacre; 15545C-21 regional anesthesia series products are composed of sterile components (unless otherwise specified in the product range); disposable equipment designed to perform epidural anesthesia; spinal; epidural/spinal cord combination; nerves Block; lumbar puncture and regional anesthesia procedures.Spine products consist of spinal needles; puncture needles and accessories needed to perform spinal surgery.Vision particles in glass ampoules of 5% lidocaine hydrochloride and 7.5% glucose injection; US Pharmacopoeia; 2 ml ampoules; NDC # 0409-4712-01; Hospira batch number 23-227-DK.These ampoules are contained in some Portex spinal anesthesia trays.
Smith Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Tray – Portex¿Regional anesthesia tray and medication; 15548-20 regional anesthesia series products consist of sterile components (unless otherwise specified in the product range); disposable equipment designed to perform epidural anesthesia; spinal; epidural/spinal cord combination; nerves Block; lumbar puncture and regional anesthesia procedures.Spine products consist of spinal needles; puncture needles and accessories needed to perform spinal surgery.Vision particles in glass ampoules of 5% lidocaine hydrochloride and 7.5% glucose injection; US Pharmacopoeia; 2 ml ampoules; NDC # 0409-4712-01; Hospira batch number 23-227-DK.These ampoules are contained in some Portex spinal anesthesia trays.
Smith Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Tray – Portex¿Spinal Tray Medicine 25g Whitacre; 15597-20 regional anesthesia series products are composed of sterile components (unless otherwise specified in the product range); disposable equipment designed to perform epidural anesthesia; spinal; epidural/spinal cord combination; nerves Block; lumbar puncture and regional anesthesia procedures.Spine products consist of spinal needles; puncture needles and accessories needed to perform spinal surgery.Vision particles in glass ampoules of 5% lidocaine hydrochloride and 7.5% glucose injection; US Pharmacopoeia; 2 ml ampoules; NDC # 0409-4712-01; Hospira batch number 23-227-DK.These ampoules are contained in some Portex spinal anesthesia trays.
Smith Medical ASD; Inc. Nov-05-2013 Spinal Anesthesia Tray – Portex¿Spinal Tray Medicine 25g Whitacre; 15597C-20 regional anesthesia series products are composed of sterile components (unless otherwise specified in the product range); disposable equipment designed to perform epidural anesthesia; spinal; epidural/spinal cord combination; nerves Block; lumbar puncture and regional anesthesia procedures.Spine products consist of spinal needles; puncture needles and accessories needed to perform spinal surgery.Vision particles in glass ampoules of 5% lidocaine hydrochloride and 7.5% glucose injection; US Pharmacopoeia; 2 ml ampoules; NDC # 0409-4712-01; Hospira batch number 23-227-DK.These ampoules are contained in some Portex spinal anesthesia trays.
Smith Medical ASD; Inc. Spinal Anesthesia Tray on November 5, 2013 – Portex¿The 4745-20 regional anesthesia series products consist of sterile components (unless otherwise specified in the product range); disposable equipment designed to perform epidural anesthesia; spinal; epidural/spinal cord combination; nerve block; lumbar puncture and Regional anesthesia procedures.Spine products consist of spinal needles; puncture needles and accessories needed to perform spinal surgery.Vision particles in glass ampoules of 5% lidocaine hydrochloride and 7.5% glucose injection; US Pharmacopoeia; 2 ml ampoules; NDC # 0409-4712-01; Hospira batch number 23-227-DK.These ampoules are contained in some Portex spinal anesthesia trays.
Smith Medical ASD; Inc. Spinal Anesthesia Tray on November 5, 2013 – Portex¿Saddleblock Tray with Drugs 22g Quincke (not including introducer); 4792-20 regional anesthesia series products are composed of sterile (unless otherwise specified in the product range); disposable equipment designed to perform epidural anesthesia; spinal; rigid Extramembrane/spinal cord combination; nerve block; lumbar puncture and regional anesthesia procedures.Spine products consist of spinal needles; puncture needles and accessories needed to perform spinal surgery.Vision particles in glass ampoules of 5% lidocaine hydrochloride and 7.5% glucose injection; US Pharmacopoeia; 2 ml ampoules; NDC # 0409-4712-01; Hospira batch number 23-227-DK.These ampoules are contained in some Portex spinal anesthesia trays.
Smith Medical ASD; Inc. Spinal Anesthesia Tray on November 5, 2013 – Portex¿Spinal Tray Medicine 22g Whitacre/25g Whitacre; 15248C-22/25 regional anesthesia series products consist of sterile components (unless otherwise specified in the product range); disposable equipment designed to perform epidural anesthesia; spinal; epidural / Spinal cord joint; nerve block; lumbar puncture and regional anesthesia procedures.Spine products consist of spinal needles; puncture needles and accessories needed to perform spinal surgery.Vision particles in glass ampoules of 5% lidocaine hydrochloride and 7.5% glucose injection; US Pharmacopoeia; 2 ml ampoules; NDC # 0409-4712-01; Hospira batch number 23-227-DK.These ampoules are contained in some Portex spinal anesthesia trays.
Smith Medical ASD; Inc. Spinal Anesthesia Tray on November 5, 2013 – Portex¿The 4795-20 regional anesthesia series products consist of sterile components (unless otherwise specified in the product range); disposable equipment designed to perform epidural anesthesia; spinal; epidural/spinal cord combination; nerve block; lumbar puncture and Regional anesthesia procedures.Spine products consist of spinal needles; puncture needles and accessories needed to perform spinal surgery.Vision particles in glass ampoules of 5% lidocaine hydrochloride and 7.5% glucose injection; US Pharmacopoeia; 2 ml ampoules; NDC # 0409-4712-01; Hospira batch number 23-227-DK.These ampoules are contained in some Portex spinal anesthesia trays.
Smith Medical ASD; Inc. Spinal Anesthesia Tray on November 5, 2013 – Portex¿Spinal Tray Medicine 22g/25g Quincke; 15249-21 regional anesthesia series products consist of sterile components (unless otherwise specified in the product range); disposable equipment designed to perform epidural anesthesia; spinal; epidural/spinal cord combination ; Nerve block; lumbar puncture and regional anesthesia procedures.Spine products consist of spinal needles; puncture needles and accessories needed to perform spinal surgery.Vision particles in glass ampoules of 5% lidocaine hydrochloride and 7.5% glucose injection; US Pharmacopoeia; 2 ml ampoules; NDC # 0409-4712-01; Hospira batch number 23-227-DK.These ampoules are contained in some Portex spinal anesthesia trays.
Beckman Coulter Company November 5, 2013 Beckman Coulter AU480; AU680; AU5800; and AU5400 Clinical Analyzer-ISE REF Valve; AU480 Part Number MU7638; AU680; and AU5800 Chemical Analyzer.An automated chemical analyzer that measures analytes in a sample.This recall is because Beckman Coulter has confirmed that some AU clinical chemistry analyzer ISE devices may have premature failure of the ISE REF (reference) valve.Premature valve failure can be detected by the presence of bubbles in the ISE REF solution tube on the ISE device.If there are bubbles; the accuracy of the ISE test results may be affected.
Beckman Coulter Company November 5, 2013 Beckman Coulter AU400; AU640; AU2700; and AU5400 Clinical Analyzer-ISE REF Valve; AU400 part number MU3226; AU640; AU2700; and AU5400 Chemical Analyzer.An automated chemical analyzer that measures analytes in a sample.This recall is because Beckman Coulter has confirmed that some AU clinical chemistry analyzer ISE devices may have premature failure of the ISE REF (reference) valve.Premature valve failure can be detected by the presence of bubbles in the ISE REF solution tube on the ISE device.If there are bubbles; the accuracy of the ISE test results may be affected.
Ethicon Endo-Surgery Inc November 5, 2013 SAGB QuickClose Sweden adjustable gastric band, including speed injection port and applicator-adjustable gastric band; individually packaged in transparent PETG inner and outer blister with Tyvek lid.Product use: Used in the surgical treatment of morbid obesity during aging research; the company determined that the gastric band could not pass the mandatory lock-in test requirements.
Ethicon Endo-Surgery Inc Nov-05-2013 SAGB QuickClose Sweden adjustable gastric band (with titanium port)-adjustable gastric band; individually packaged in transparent PETG inner and outer blister with Tyvek lid.Product use: Used in the surgical treatment of morbid obesity during aging research; the company determined that the gastric band could not pass the mandatory lock-in test requirements.
Ethicon Endo-Surgery Inc. realized on November 5, 2013-Adjustable gastric band; individually packaged in transparent PETG inner and outer blister with Tyvek lid; or in various kit configurations, each kit comes with a strap.Product use: Designed to be used in the surgical treatment of morbid obesity during aging research; the company determined that the gastric band could not pass the mandatory lock-in test requirements.
Roche Diagnostics Business; Inc. Nov-05-2013 COBAS INTEGRA 800 Analyzer-COBAS INTEGRA 800 Analyzer and Software 9864.C2Cobas.COBAS Part No. 28122474001; 28122474692; 04559126001; 04589459970 Corresponding to the analyzer with or without closed tube sampling accessories for clinical chemical analysis fully automated system for in vitro quantitative / qualitative determination of analytes in body fluids.Roche COBAS INTEGRA 800 system; software version 9864.C2 does not perform necessary ISE service operations.Whenever the ISE rack is removed; the ISE counter in the software is reset to zero, and the system will not automatically perform the corresponding service operations.In addition; certain maintenance activities that must be performed manually by the operator are not required on the software
Fresenius Medical Holdings; Inc. November 5, 2013 Fresenius – Fresenius Liberty® Cycler Part Number: RTLR180111 Product Usage: The Liberty Cycler is a portable device designed for acute and chronic peritoneal dialysis.Liquid leakage may be observed in the pump compartment of Liberty Cycler, which may cause the dialysate to be contaminated; may cause peritonitis
Invacare Corporation Nov-05-2013 Aquatec Ocean VIP – Aquatec Ocean VIP; Aquatec Ocean double VIP; Aquatec Ocean E-VIP mobile shower and toilet toilet with tilt function.Movable showers and toilet seats with tilt function The snap fixing devices of the back cushions on the mobile showers and toilet seats Aquatec Ocean VIP and Ocean Dual VIP cannot withstand the required pulling force of 500 N; when the product is in the reclining position and/ Or when used in an inclined position.This may cause the snap-in fixture to unlock.
Handicare Accessibility Nov-06-2013 Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss) of Handicare USA; Mobile phone – Mobile phone components of Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss) of Handicare USA; Part No. BP300-100/BP300-400RSUS ( Mobile phone)-model BBR0311USAB (blue) and BBR0311USSS (silver) mobile phone component equipment operating Minivator Bath Bliss Reclining Bath Lift; non-AC powered patient lift composed of electric actuators; powered mechanical seat device; temporarily fixed in In the bathtub; used to lift and lower the patient in a vertical or reclining position while taking a bath.The company realized that when the user was in the bathtub, the two phones in the affected batch could not be used.
Post time: Dec-23-2021
