BEUDAMED
    FDA Enforcement Class II Ongoing

    Pilling Wecksorb Cylindrical Sponges

    Recall: Z-0772-2023 · Reported January 4, 2023

    Enforcement

    Recall Number
    Z-0772-2023
    Event ID
    91312
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TELEFLEX LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 4, 2023
    Initiation Date
    September 28, 2022
    Classification Date
    December 28, 2022
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437, United States

    Description

    Pilling Wecksorb Cylindrical Sponges

    Reason

    Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

    Code Info

    Catalog Number: 200400, Lot Number: 22B0395

    Distribution

    Domestic distribution to IL, MS, PA, TN.

    Quantity

    1,000 units