BEUDAMED
    FDA Recall Open, Classified

    Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

    Recall: Z-0655-2020 · Initiated October 18, 2019

    Recall

    Recall Number
    Z-0655-2020
    Event Number
    84178
    Firm
    CP Medical Inc
    FEI Number
    3012164473
    Product Code
    GAM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 18, 2019
    Address
    1775 Corporate Dr, Ste 150, Norcross, GA, 30093-2960

    Description

    Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

    Reason

    Failed to meet USP minimum average value for knot pull (tensile) strength.

    Action

    Affected customers and distributors were contacted via email on October 18, 2019 and a follow-up certified letter was sent on October 22, 2019. Those end users not contacted by CP Medical directly will be contacted by their distributor. Please contact 470-273-6049 for recall information.

    Distribution

    USA - product distributed in CA, OH, WA, PA, KY, UT, FL, TN, SC, IA, NE

    Quantity

    174 boxes 12 per box (plus 36 samples) - total of 2124 sutures