BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1872-2017
    Event ID
    76875
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CP Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 26, 2017
    Initiation Date
    February 2, 2017
    Classification Date
    April 20, 2017
    Address
    1775 Corporate Dr Ste 150, N/A, Norcross, GA, 30093-2960, United States

    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.

    Code Info

    Lot Numbers - 150323-04, 150324-04, 150520-10, 150615-01, 150616-08, 150709-01, 151229-64, 160414-69, 160510-59, 160617-52, 160824-50

    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