BEUDAMED
    FDA Enforcement Class I Terminated

    Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B

    Recall: Z-1557-2021 · Reported May 19, 2021

    Enforcement

    Recall Number
    Z-1557-2021
    Event ID
    87722
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Action Industries, Inc. 306
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 19, 2021
    Initiation Date
    April 9, 2021
    Classification Date
    May 12, 2021
    Termination Date
    October 3, 2023
    Address
    25 Heywood Rd, Arden, NC, 28704-9302, United States

    Description

    Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B

    Reason

    Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

    Code Info

    Kit Number: 79544B; UDI (GTIN): 20809160341855; Lot Number: 0000282089 (Expiration Date: 02/12/2022)

    Distribution

    Distributed US nationwide to OH, OR, FL and CA.

    Quantity

    10 cases (20 kits per case)