BEUDAMED
    FDA Enforcement Class II Ongoing

    Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.

    Recall: Z-1027-2019 · Reported March 27, 2019

    Enforcement

    Recall Number
    Z-1027-2019
    Event ID
    82197
    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
    March 27, 2019
    Initiation Date
    February 4, 2019
    Classification Date
    March 19, 2019
    Address
    1775 Corporate Dr Ste 150, N/A, Norcross, GA, 30093-2960, United States

    Description

    Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.

    Reason

    Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.

    Code Info

    Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)

    Distribution

    Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.

    Quantity

    1,905 boxes (22,860 sutures total)