BEUDAMED
    FDA Enforcement Class I Terminated

    FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03

    Recall: Z-1786-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1786-2021
    Event ID
    87720
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avid Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 16, 2021
    Initiation Date
    April 9, 2021
    Classification Date
    June 4, 2021
    Termination Date
    July 18, 2022
    Address
    9000 Westmont Dr, N/A, Toano, VA, 23168-9351, United States

    Description

    FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03

    Reason

    Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.

    Code Info

    Part Number:VAMK024-03; Package GTIN: 20809160342500; Lot Number: 1445301 (Expiration Date: 04/30/2022) and 1445302 (Expiration Date: 04/30/2022)

    Distribution

    Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN

    Quantity

    160 kits