BEUDAMED
    FDA Recall Open, Classified

    Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457

    Recall: Z-0909-2023 · Initiated December 2, 2022

    Recall

    Recall Number
    Z-0909-2023
    Event Number
    91280
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    HBA
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 2, 2022
    Posted
    January 6, 2023
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650

    Description

    Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457

    Reason

    Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

    Action

    On December 2, 2022, the firm notified customers via "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letters. Customers were instructed to immediately remove units of affected product from service. Customers should complete the Acknowledgement Form and return to the recalling company. Once received, Customer Service will contact the customer to aid them in returning the affected product. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected]

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, PA, TX, VA, WV and the countries of Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.

    Quantity

    168 US; 3 OUS