BEUDAMED
    FDA Recall Terminated

    B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton.

    Recall: Z-1163-06 · Initiated May 8, 2006

    Recall

    Recall Number
    Z-1163-06
    Event Number
    35554
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 8, 2006
    Posted
    June 24, 2006
    Terminated
    August 22, 2006
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton.

    Reason

    Mislabeled-9F labeled units actually contain 10F devices

    Action

    The recalling firm telephoned their consignees on 5/10/06 to inform them of the problem and the need to recall their kits

    Distribution

    The product was shipped to four consignees in FL, NY, CT, and Germany that repack the product into their own kits.

    Quantity

    9300 units