BEUDAMED
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    VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. Contents: Elution Buffer A , 1 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set CD ROM - 1 Calibrator/Diluent Set Whole Blood Primer, 6 x 1 mL Sample vials, 2 x 100 Instruction Manual Bio-Rad Laboratories, Inc., 400 Alfred nobel Drive, Hercules, CA 94547-1803. Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HLCP).

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code KRZ·October 25, 2011

    Vicks brand Warm Mist Humidifier, Model V610, ''Pure Warm Moisturizer for Soothing Relief of Cold and Flu Symptoms'' sold over the counter. Firm on the label: Distributed by Kaz Inc., under license from the Procter & Gamble Company, Cincinnati, OH 45202. UPC code 3 28785 20610 4.

    FDA Recall
    Terminated ·Product code KFZ·April 15, 2003

    Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 16, 2019

    Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·May 7, 2014

    Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany, Surgical Implant, Clip - Piston MVP Titanium, REF: 1006 711, Lot 2 09 13 06. Product is designed for ossicular replacement to functionally restore the middle ear in cases of pathologic changes of the conductive hearing mechanism.

    FDA Recall
    Terminated ·Heinz Kurz GmbH Medizintechnik Tuebinger Strasse 3 Dillingen Germany·Product code ETA·April 27, 2011

    LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the Plum Series Infuser; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 11235-03

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·May 6, 2005

    LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Prepierced Injection Site and Option-Lok, Dual Channel Capped Secondary Port; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 11235-03

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·September 29, 2005

    HoverMatt Patient Transfer Solution/Air Transfer Mattress

    FDA Recall
    Terminated ·D.T. Davis Enterprises Ltd.·Product code FRZ·September 13, 2005

    List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·April 1, 2013

    List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·April 1, 2013

    List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·April 1, 2013

    Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.

    FDA Recall
    Terminated ·Genesis BPS, LLC.·Product code BRZ·July 17, 2014

    Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 107'', 2 Injection Sites, Male Luer Lock Adapter, catalog 4C7774; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code BRZ·July 16, 2003

    Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112'', Standard Blood Filter, 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 2C6750; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code BRZ·July 16, 2003

    Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', Large Standard Blood Filter, 170 to 260 Micron Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C7623; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code BRZ·July 16, 2003

    Fenwal Y-Type Blood/Solution Set with Large Standard Blood Filter, 15 drops/mL, 89'', 170 to 260 Micron Filter, Large Bore Tubing, Male Luer Lock Adapter, catalog 4C7776A; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code BRZ·July 16, 2003

    List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·April 1, 2013

    LifeShield Latex-Free HEMA Y-Type Blood PlumSet, Nonvented, 122 inch, with 210 Micron Filter, Inline Dual Channel Cassette, 2 Clave Ports and Option-Lok for use with Plum Series Infusers; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12259-02

    FDA Recall
    Terminated ·Hospira Inc.·Product code BRZ·September 29, 2005

    Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion

    FDA Recall
    Terminated ·Genesis BPS, LLC.·Product code BRZ·July 17, 2014

    Fenwal Straight Type Blood Set with Large Standard Blood filter, 15 drops/mL, 80'', 170 to 260 Micron Filter, Injection Site, Male Luer Lock Adapter, catalog 4C6766; Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code BRZ·July 16, 2003