BEUDAMED
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    Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DKB·August 11, 2009

    Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DLZ·August 11, 2009

    SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·November 19, 2018

    Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·August 9, 2019

    ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study

    FDA Recall
    Terminated ·Salter Laboratories, Division of Regulatory Affairs·Product code BZQ·December 21, 2010

    Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.

    FDA Recall
    Terminated ·Mallinckrodt Inc·Product code IZQ·May 20, 2011

    Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-Flarsheim Company, Cincinnati, OH The Liebel Flarsheim Illumena 150mL Syringes with Handi-Fil Straw are designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures.

    FDA Recall
    Terminated ·Mallinckrodt Inc·Product code IZQ·October 11, 2011

    The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension system.

    FDA Recall
    Terminated ·Mallinckrodt Inc·Product code IZQ·April 7, 2008

    Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZQ·June 4, 2004

    ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch

    FDA Recall
    Terminated ·Convatec Inc.·Product code EZQ·September 17, 2010

    Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0

    FDA Recall
    Terminated ·CAS Medical Systems, Inc.·Product code BZQ·May 24, 2004