BEUDAMED
    FDA Enforcement Class II Terminated

    Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

    Recall: Z-0403-2022 · Reported December 29, 2021

    Enforcement

    Recall Number
    Z-0403-2022
    Event ID
    89119
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 29, 2021
    Initiation Date
    December 1, 2021
    Classification Date
    December 20, 2021
    Termination Date
    February 28, 2024
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

    Reason

    There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.

    Code Info

    Lot number: 20C04; Serial Numbers: 1260004700 and 1259882880; UDI Code: (01)00384401017752(11)200304(17)250228(21)1260004700GS(10)20C04 (01)00384401017752(11)200304(17)250228(21)1259882880GS(10)20C04

    Distribution

    US Nationwide distribution in the states of IL and NC.

    Quantity

    2