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    Simplastin HTF Reagents, 20ml HO, ( and 6 ml HO) bioMerieux, Inc., Durham, NC 27704

    FDA Recall
    Terminated ·BIOMERIEUX, INC.·Product code GJS·March 7, 2005

    Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set, 9104444 ATF-120 Fast Start Kits (AT-3), or 9108444 ATF-40 Fast Start Kits AT-3) Product Usage: The Fresenius Kabi CATSmart device (Continuous auto transfusion System) is indicated for the processing of autologous shed blood collected interaoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. The CATSmart Auto transfusion System is designed to reduce the need for allogeneic blood transfusion by re-infusing a patient s own lost blood during surgery. The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous re-infused blood (auto transfusion). This is a single-use device.

    FDA Recall
    Terminated ·Fenwal Inc·Product code CAC·March 5, 2019

    Part Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak 4/5 Bone Screw AM-0030-S 30.0mm Acutrak 4/5 Bone Screw AM-0035-S 35.0mm Acutrak 4/5 Bone Screw AM-0040-S 40.0mm Acutrak 4/5 Bone Screw AM-0045-S 45.0mm Acutrak 4/5 Bone Screw AM-0050-S 50.0mm Acutrak 4/5 Bone Screw AP-67100-S 100mm Acutrak 6/7 Fixation Screw AP-67105-S 105mm Acutrak 6/7 Fixation Screw AP-67110-S 110mm Acutrak 6/7 Fixation Screw AP-67115-S 115mm Acutrak 6/7 Fixation Screw AP-67120-S 120mm Acutrak 6/7 Fixation Screw AP-6740-S 40mm Acutrak 6/7 Fixation Screw AP-6745-S 45mm Acutrak 6/7 Fixation Screw AP-6750-S 50mm Acutrak 6/7 Fixation Screw AP-6755-S 55mm Acutrak 6/7 Fixation Screw AP-6760-S 60mm Acutrak 6/7 Fixation Screw AP-6765-S 65mm Acutrak 6/7 Fixation Screw AP-6770-S 70mm Acutrak 6/7 Fixation Screw AP-6775-S 75mm Acutrak 6/7 Fixation Screw AP-6780-S 80mm Acutrak 6/7 Fixation Screw AP-6785-S 85mm Acutrak 6/7 Fixation Screw AP-6790-S 90mm Acutrak 6/7 Fixation Screw AP-6795-S 95mm Acutrak 6/7 Fixation Screw ATF-140-S 14.0mm Acutrak Fusion Device ATF-160-S 16.0mm Acutrak Fusion Device ATF-180-S 18.0mm Acutrak Fusion Device ATF-200-S 20.0mm Acutrak Fusion Device ATF-220-S 22.0mm Acutrak Fusion Device ATF-240-S 24.0mm Acutrak Fusion Device ATF-270-S 27.0mm Acutrak Fusion Device ATF-320-S 32.0mm Acutrak Fusion Device ATF-370-S 37.0mm Acutrak Fusion Device ATM-100-S 10.0mm Mini Acutrak Fixation Screw ATM-120-S 12.0mm Mini Acutrak Fixation Screw ATM-140-S 14.0mm Mini Acutrak Fixation Screw ATM-160-S 16.0mm Mini Acutrak Fixation Screw ATM-180-S 18.0mm Mini Acutrak Fixation Screw ATM-200-S 20.0mm Mini Acutrak Fixation Screw ATM-220-S 22.0mm Mini Acutrak Fixation Screw ATM-240-S 24.0mm Mini Acutrak Fixation Screw ATM-260-S 26.0mm Mini Acutrak Fixation Screw

    FDA Recall
    Open, Classified ·Acumed LLC·Product code HWC·November 29, 2022

    The box label states: "ATF 40 Fast Start Kit 9108491...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The ATF 40 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. ATS is a suction line to aspirate and add anticoagulate to shed blood from the surgical field into an autotransfusion reservoir (ATR). The ATS has a inch. suction port and is connected to a vacuum source. ATR is an autotransfusion reservoir to collect, de-foam, filter, and store blood prior to processing. The ATR reservoirs are offered with either a 120 micron or a 40 micron filter. ATF 40 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.

    FDA Recall
    Terminated ·Fresenius Kabi, LLC·Product code CAC·March 29, 2010

    ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. The component that is the subject of the recall is the AT1 Autotransfusion Set.

    FDA Recall
    Terminated ·Fresenius Hemocare, Inc.·Product code CAC·January 21, 2003

    The box label states: "ATF 120 Fast Start Kit 9108501...STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The ATF120 Fast Start Kit contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR120 Autotransfusion Reservoir. ATS is a suction line to aspirate and add anticoagulate to shed blood from the surgical field into an autotransfusion reservoir (ATR). The ATS has a 1/4 inch. suction port and is connected to a vacuum source. ATR is an autotransfusion reservoir to collect, de-foam, filter, and store blood prior to processing. The ATR reservoirs are offered with either a 120 micron or a 40 micron filter. ATF 120 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.

    FDA Recall
    Terminated ·Fresenius Kabi, LLC·Product code CAC·March 29, 2010

    SurFlo IV Catheter

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code FOZ·August 5, 2015

    Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Recall
    Terminated ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019

    rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

    radial head implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

    #2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

    #4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

    radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

    rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

    rHead Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

    rHead Recon Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

    Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697), Product Code 66745; b) STERILE "1" EAR CURETTE (505629), Product Code 67050; c) STERILE FOX DERMAL CURETTE, 5MM(32923), Product Code 67430; d) STERILE EXCAVATOR CURETTE (P/S), Product Code I67970; e) ST BUCK EAR CURETTE BLNT STR SZ 00, Product Code I68040; f) STERILE BRUNS CURETTE #4 (BC400S), Product Code I68340; g) 6MM FOX DERMAL CURETTE STERILE, Product Code I68380; h) STERILE KEVORKIAN CURETTE 4MM (KEC4S), Product Code I68470; i) ST ENDOCERVICAL BIOPSY CURETTE 2MM, Product Code I68480

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code HTF·February 23, 2024

    #1 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

    rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017

    rHead Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LTF·October 24, 2017