BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated February 4, 2019

    Recall

    Recall Number
    Z-1027-2019
    Event Number
    82197
    Firm
    CP Medical Inc
    FEI Number
    3012164473
    Product Code
    GAL
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 4, 2019
    Address
    1775 Corporate Dr, Ste 150, Norcross, GA, 30093-2960

    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.

    Action

    CP Medical initially notified consignees via telephone call on about 02/01/2019. Consignees were gain notified via "URGENT: Recall Notice" via email on about 02/04/2019 and followed up with the same letter sent via FedEx on about 02/20/2019. Instructions included to immediately discontinue selling or using the affected product, return any affected product back to CP Medical, notify customers if the affected product was further distributed, and complete and return the "Recall Checklist." A request for a Returns Goods Authorization (RGA) and questions can be directed to Customer Service at 800-950-2763 and [email protected]

    Distribution

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

    Quantity

    1,905 boxes (22,860 sutures total)