BEUDAMED
    FDA Recall Terminated

    Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100

    Recall: Z-1118-2022 · Initiated March 22, 2022

    Recall

    Recall Number
    Z-1118-2022
    Event Number
    90050
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    EFQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 22, 2022
    Terminated
    January 29, 2024
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100

    Reason

    Product not approved for release for US distribution

    Action

    Crosstex notified accounts by Urgent Medical Device Recall letter dated 3/22/22 via email. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect on-hand inventory for Ultra Pure Non-Woven Sponges, lot #202108 (part numbers ENC100 and ENC4100). 2. Please reply via email or complete the Recall Response Form included with this Notification Letter and return to [email protected]. Crosstex will provide instructions for returning the affected product to us. 3. Identify and notify all Customers who you have further distributed the affected product. Impacted Customers shall be provided with a copy of this letter and Recall Response Form. 4. Your Customer s Recall Response Forms shall be collected and reconciled to your distribution records to ensure all affected product is accounted for. 5. Crosstex will coordinate return of the product and credit issuance upon receipt of the completed Recall Response Form. If you have questions regarding this matter, please contact me at 312-579-9258.

    Distribution

    Nationwide

    Quantity

    103 cases