BEUDAMED
    FDA Enforcement Class II Ongoing

    Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A

    Recall: Z-0287-2025 · Reported November 13, 2024

    Enforcement

    Recall Number
    Z-0287-2025
    Event ID
    95464
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Surgical Company, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 13, 2024
    Initiation Date
    September 18, 2024
    Classification Date
    November 1, 2024
    Address
    45 Congress St Ste 153, N/A, Salem, MA, 01970-5998, United States

    Description

    Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A

    Reason

    Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.

    Code Info

    UDI-DI: 10749915000039 Lot Number Expiration Date: 2023/03 AQ 2028/03/31; 2023/06 AP 2028/06/30; 2023/10 BO 2028/10/31; 2023/12 AY 2028/12/31; 2024/05 AE 2029/05/31; 2024/06 AQ 2029/06/30

    Distribution

    CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy

    Quantity

    390 units