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

    Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pack Number DYNJ0774005G; 6) PICC/RAD SPEC PROC 0906165-LF, Pack Number DYNJ32773G; 7) VAP PACK-LF, Pack Number PHS656578F

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·February 11, 2025

    Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients while in the lifter. Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·April 10, 2008

    KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired

    FDA Recall
    Terminated ·KT Health, LLC·Product code IME·September 16, 2019

    KING LT -D Laryngeal Tube, Size 2.5 KLTD2025, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    KING LT -D Size 3, 10-0002, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    KING LT-D Size 5, 10-0004, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    KING LTS -D, Size 5, 10-0027, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    KING LTS -D, Size 4, 10-0026, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    KING LT -D Laryngeal Tube, Size 4, KLTD204, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    Cardiac ResQ Kit, Size 4, CRQ424, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    Cardiac ResQ Kit , Size 3, CRQ423, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    KING LTS -D, Size 3, 10-0025, Oropharyngeal Airway. King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    KING LT -D Size 4, 10-0003, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    KING LT -D Laryngeal Tube, Size 2, KLTD202, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    KING LT -D Lanyngeal Tube, Size 3, KLTD203, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    Cardiac ResQ Kit, Size 5, CRQ425, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

    Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code KLT·June 11, 2003

    VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code KLT·March 5, 2014