BEUDAMED
    FDA Recall Open, Classified

    PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493

    Recall: Z-1872-2017 · Initiated February 2, 2017

    Recall

    Recall Number
    Z-1872-2017
    Event Number
    76875
    Firm
    CP Medical Inc
    FEI Number
    3012164473
    Product Code
    GAM
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    February 2, 2017
    Address
    1775 Corporate Dr, Ste 150, Norcross, GA, 30093-2960

    Description

    PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493

    Reason

    The tensile strength minimum as directed by USP <881> was not met over the length of the product's shelf life.

    Action

    The affected distributors/customers were contacted directly via telephone or by e-mail on February 6-7, 2017. Those end users not contacted by CP Medical directly will be contacted by their distributor

    Distribution

    AL, AZ, AR, CA, CO, CT, FL, ID, IL, IN, KY, LA, MT, NE, NJ, NM, NY, OK, OR, SC, TX, WA and South Africa

    Quantity

    504 boxes/12 sutures - 6,048 individual sutures