BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0909-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0909-2023
    Event ID
    91280
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2023
    Initiation Date
    December 2, 2022
    Classification Date
    January 6, 2023
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650, United States

    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.

    Code Info

    UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027

    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