BEUDAMED
    FDA Recall Terminated

    BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.

    Recall: Z-2378-2018 · Initiated January 12, 2018

    Recall

    Recall Number
    Z-2378-2018
    Event Number
    80197
    Firm
    Medline Industries, Inc.
    FEI Number
    3000717925
    Product Code
    OFF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 12, 2018
    Terminated
    July 22, 2020
    Address
    1170 S Northpoint Blvd, Waukegan, IL, 60085-6757

    Description

    BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.

    Reason

    One of the cases of product might not have been sterilized.

    Action

    The recalling firm's sales representative telephoned their one customer on 1/12/2018 requesting return of the product.

    Distribution

    The product was distributed to UT.

    Quantity

    6/5-kit cases