BEUDAMED
    FDA Enforcement Class II Terminated

    AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545

    Recall: Z-1038-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-1038-2020
    Event ID
    84733
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    January 11, 2020
    Classification Date
    February 5, 2020
    Termination Date
    January 19, 2023
    Address
    1350 Bridge Dr, N/A, Waukegan, IL, 60085-6306, United States

    Description

    AAMI 3 NON-REINF SURG GWN XL 2 TWL, Gown Item Code ASG9545

    Reason

    The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.

    Code Info

    Lot Numbers: XXXXJXXX Single-Sterile Lot Format: YYMRJXXX Where: YY Last two digits of the year ( 18 or '19) M Month in alpha code " If made in 2018 o J for September o K for October o L for November OR o M for December " If made in 2019, any value is affected R Product revision or suffix P Facility code is letter J XXX Sequential Number - Monthly reset OR Bulk Non-Sterile Lot Format: XXXYRPQ Where: XXX Elapsed days of year " " If made in 2018, 244 or greater is affected OR " " If made in 2019, any value is affected; see below for year made identifier Y Last character of year gown was made (2018 or 2019) R Product Revision P Facility code is letter J Q Plant shift identifier; this identifier was added during the affected time period and therefore older product may not contain this digit in the lot number

    Distribution

    Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.

    Quantity

    7,659,634 total units