BEUDAMED
    FDA Recall Terminated

    PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch.

    Recall: Z-0974-05 · Initiated May 16, 2005

    Recall

    Recall Number
    Z-0974-05
    Event Number
    32194
    Firm
    Theragenics Corporation
    FEI Number
    1037598
    Product Code
    KXK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 16, 2005
    Posted
    July 7, 2005
    Terminated
    October 5, 2005
    Address
    5203 Bristol Industrial Way, Buford, GA, 30518-1799

    Description

    PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch.

    Reason

    The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date.

    Action

    Consignees were contacted on 5/16/2005 via telephone and email.

    Distribution

    OH, VA

    Quantity

    13 loads