BEUDAMED
    FDA Recall Open, Classified

    Pilling Wecksorb Cylindrical Sponges

    Recall: Z-0772-2023 · Initiated September 28, 2022

    Recall

    Recall Number
    Z-0772-2023
    Event Number
    91312
    Firm
    TELEFLEX LLC
    FEI Number
    3005747797
    Product Code
    EFQ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 28, 2022
    Posted
    December 28, 2022
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    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.

    Action

    Consignees were notified on about 09/28/2022, via letter. Consignees were instructed to immediately discontinue use and quarantine the products on hand, complete and return the enclosed Acknowledgement Form via fax to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products.

    Distribution

    Domestic distribution to IL, MS, PA, TN.

    Quantity

    1,000 units