BEUDAMED
    FDA Enforcement Class II Terminated

    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

    Recall: Z-1517-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1517-2020
    Event ID
    85049
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avid Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2020
    Initiation Date
    February 18, 2020
    Classification Date
    March 19, 2020
    Termination Date
    November 23, 2020
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351, United States

    Description

    Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

    Reason

    The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

    Code Info

    Item Codes: ADBR043-08, ADCO001-20, ADCO001-20, ADCO002-15, ADCO005-29, ADCO007-21, ADVC015-23, ADVC032-21, ADVC046-12, ADVH073-13, ADVM040-07, ADVM050-02, SHER020-10, SINA223, VAHT026-07, YAVA115-04, YAVA130, YAVA131-03. Lot numbers: 1333107, 1333471, 1336767, 1337370, 1339098, 1339331, 1342016, 1347760, 1347896, 1348407, 1353068, 1353419, 1354811, 1357043, 1359839, 1360420, 1361445, 1363245, 1365971, 1367018, 1367137, 1367218, 1367987, 1368726, 1369130, 1370525, 1370700, 1370929, 1371222, 1372022, 1372310, 1372407, 1373347, 1374864, 1375307, 1375787, 1376196, 1376397, 1378227, 1380392, 1380874, 1381757, 1382980, 1383533, 1384526, 1385192. Expiration Dates: 9/30/2020-10/17/2022

    Distribution

    US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

    Quantity

    1,644 each