BEUDAMED
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    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code FMZ·June 30, 2021

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·August 25, 2021

    Burke Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX, model number 7064

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code FNL·March 22, 2004

    KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code INX·March 22, 2004

    KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IKZ·March 22, 2004

    KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IOQ·March 22, 2004

    EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.

    FDA Recall
    Terminated ·Edwards Lifesciences Research Medical Inc·Product code DWF·November 19, 2004

    Cold Therapy Blanket

    FDA Recall
    Terminated ·DeRoyal Technologies Inc·Product code ILO·November 22, 2004

    Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.

    FDA Recall
    Terminated ·DPC Cirrus·Product code DHA·October 29, 2004

    AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code JJE·March 22, 2004

    Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202

    FDA Recall
    Terminated ·Alveolus, Inc.·Product code FWN·April 22, 2004

    Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, ***1000 ml Lot***Sterile EO***Manufactured and Distributed by***Rusch Inc. 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 1

    FDA Recall
    Terminated ·Teleflex Medical, Inc.·Product code KNX·May 13, 2004

    Latex Free*** REF B1000P Belly Bag Urine Collection Bag with Sample Port***1000 ml LOT***Sterile EO*** Single use only, Manufactured and Distributed by***Rusch Inc., 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 10****

    FDA Recall
    Terminated ·Teleflex Medical, Inc.·Product code KNX·May 13, 2004

    Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Manufactured by Sterion Incorporated, Ham Lake, MN for Argon Medical Devices, Athens, Texas.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code KDC·June 22, 2004

    Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code NDH·November 22, 2004

    Vitros CRP (C-Reactive Protein) Slides. Catalog #192 6740 contains 250 slides; Catalog #809 7990 contains 90 slides. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company, Rochester, NY 14626.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DCK·November 22, 2004

    PASV PICC CUSTOM KIT, 3F, single lumen - CHILDREN''S HEALTHCARE OF ATLANTA, Catalog # 60M195071, UPN # M00160M1950710. Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: Each kit contains a radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LJS·November 22, 2004

    VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT - GENESIS MEDICAL CENTER EAST, Catalog #60M120521, UPN # M00160M1205210; Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LJS·November 22, 2004

    PASV PICC, 3F, single lumen, CUSTOM KIT - VANDERBILT UNIVERSITY MEDICAL CENTER. Catalog #60M220991, UPN #M00160M2209910. Firm on label: Boston Scientific Corp, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: Each kit contains a radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LJS·November 22, 2004

    VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450, UPN #M001454500; sold as individual catheters. Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY ''. DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LJS·November 22, 2004