BEUDAMED
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    CMV IgM EIA, in vitro diagnostic.

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code LFZ·October 19, 2022

    Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code PAB·September 14, 2023

    SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. Catalog Number: SR10349

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code OHQ·November 6, 2023

    Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 5) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PEV·April 8, 2024

    Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PEV·September 4, 2024

    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

    FDA Recall
    Open, Classified ·Bard Peripheral Vascular Inc·Product code PFV·December 22, 2022

    MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PEV·November 15, 2023

    Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH; 3) DIALYSIS PACK , Pack Number DYNJ36932A ; 4) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 5) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 6) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PEV·April 8, 2024