BEUDAMED
    FDA Recall Terminated

    Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units.

    Recall: Z-0085-06 · Initiated September 24, 2005

    Recall

    Recall Number
    Z-0085-06
    Event Number
    33771
    Firm
    Surgical Specialties Corp
    FEI Number
    2522801
    Product Code
    GAR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 24, 2005
    Posted
    October 21, 2005
    Terminated
    December 14, 2005
    Address
    100 Dennis Dr, Reading, PA, 19606-3776

    Description

    Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units.

    Reason

    mislabeled as double armed straight needle actually single armed straight needle

    Action

    On 9/24/05, the recalling firm issued notifications to their customers via fax informing them of the problem and the need to return any remaining product to the recalling firm.

    Distribution

    The product was shipped to hospitals in IL, KY, NC, NE, OR, UT, and VA. The product was also shipped to distributors in FL, KY, PA, TN, and VA.

    Quantity

    27 boxes