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    Device to determine quantitative total testosterone in human serum

    FDA Recall
    Terminated ·Qualigen Inc·Product code CDZ·September 19, 2003

    The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P

    FDA Recall
    Terminated ·Qualigen Inc·Product code CDZ·November 6, 2019

    Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DDZ·January 31, 2024

    FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.

    FDA Recall
    Terminated ·Qualigen Inc·Product code CDZ·November 8, 2013

    SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDZ·January 31, 2017

    Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code CDZ·July 5, 2024

    TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable Hepatocellular carcinoma(HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion.

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion 447 March Road Ottawa Canada Ontario·Product code NAW·February 24, 2009

    Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7) 880-333/11 (Sz. 3-4 - cemented x-sm), (8) 880-333/12 (Sz. 3-4 - cemented sm), (9) 880-333/13 (Sz. 3-4 - cemented md), (10) 880-333/21 (Sz. 3-4 - cemented lg), (11) 880-333/22 (Sz. 3-4 - cemented x-lg), (12) 880-333/23 (Sz. 3-4 - cemented xx-lg), (13) 880-335/11 (Sz. 5-6 - cemented x-sm), (14) 880-335/12 (Sz. 5-6 - cemented sm), (15) 880-335/13 (Sz. 5-6 - cemented md), (16) 880-335/21 (Sz. 5-6 - cemented lg), (17) 880-335/22 (Sz. 5-6 - cemented lg), (18) 880-335/23 (Sz. 5-6 - cemented xx-lg), (19) 880-337/11 (Sz. 7-8 - cemented x-sm), (20) 880-337/12 (Sz. 5-6 - cemented sm), (21) 880-337/13 (Sz. 7-8 - cemented md), (22) 880-337/21 (Sz. 7-8 - cemented lg), (23) 880-337/22 (Sz. 7-8 - cemented x-lg), (24) 880-337/23 (Sz. 7-8 - cemented xx-lg), (25) 880-339/11 (Sz. 9-10 - cemented x-sm), (26) 880-339/12 (Sz. 9-10 - cemented sm), (27) 880-339/13 (Sz. 9-10 - cemented md), (28) 880-339/21 (Sz. 9-10 - cemented lg), (29) 880-339/22 (Sz. 9-10 - cemented x-lg), (30) 880-339/23 (Sz. 9-10 - cemented xx-lg);

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·April 3, 2025

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NJ4303 (Reorder No. 21-0426-01) described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 Luer-Activated Valve injenction Sites Burette set.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number AK2304 (Reorder No. 21-0308-01) 118 inch length/300 cm, 19ml priming volume, 60 drops/ml, 3 standard injection sites and 0.22 micron air-eliminating filter.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Smiths Medical CADD-Sentry Pro Medication Safety Software - electronic pump protocol programming software - Administrator REF 21-6275-51 RX only, Smiths Medical MD, Inc. St Paul, Minnesota 55112 USA

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FRN·August 14, 2007

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number AC2029 (Reorder No. 21-0330-01) Speciality Administration Low Adsorption Filter Set has 105 inch length/267 cm, 27.5ml priming volume, 20 drops/ml, 0 injection sites, 0.22 micron air-eliminating filter, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Pump Model 1700 pump, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. REF 21-1801-81, 21-1803-81, 21-1805-49/51/81, 21-1806-51/81, 21-1807-49

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·March 10, 2008

    CADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 USA. Electromechanical pumps used for general drug delivery infusion therapies. Used mainly by home care patients but can also used in health care facilities.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FRN·March 7, 2008

    Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J'' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code MMP·March 29, 2006

    Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Dual-lumen Fluoro-Free Venous Access System, Dual Lumen Silicone Catheter, 3.4mm O.D. tray. REF 21-8652-24. Contents: Dual-lumen Portal with WING-LOCK Connector, Radiopaque Dual-lumen PolyFlow Polyurethane Catheter, 10.2 Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, Vein Pick, 2 GRIPPER PLUS Non-Coring Safety needles 20G, 20G 90-degree PORT-A-CATH needle, 18G Extra Thin Wall Introducer Needle, 11 Fr Introducer, ''J'' Guidewire, Syringes, Tunneling Tool, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code MMP·March 29, 2006

    Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4673-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J'' Guidewires, 2 Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code MMP·March 29, 2006

    Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4653-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr Introducer, 2 ''J'' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code MMP·March 29, 2006

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Burette Administration Set described as 110 inch length/279 cm, 16.5ml priming volume, 60 drops/ml, 3 standard injection sites. Model Number I8C1630 (Reorder No. 21-0319-25) for product distributed Internationally. Model Number 8C1630 (Reorder No. 21-0306-01) for product distributed within the United States.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number LC4203 (Reorder No. 21-0341-01) 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 needleless Injection sites.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004