BEUDAMED
    FDA Recall Terminated

    SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units

    Recall: Z-0056-05 · Initiated October 14, 2004

    Recall

    Recall Number
    Z-0056-05
    Event Number
    30242
    Firm
    Thomas Medical Products Inc
    FEI Number
    3010665433
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 14, 2004
    Posted
    October 28, 2004
    Terminated
    January 24, 2006
    Address
    65 Great Valley Pkwy, Malvern, PA, 19355-1302

    Description

    SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units

    Reason

    Sheaths may fracture if exposed to excess fluorescent light

    Action

    The recalling firm issued a letter to the distributor on 10/15/04 via fax and Federal Express. The letter informed them of the product and the need to return the product. The account was instructed to conduct a sub-recall.

    Distribution

    The product was shipped to the label owner/distributor in CA.

    Quantity

    1170 kits