BEUDAMED
    FDA Recall Open, Classified

    Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.

    Recall: Z-1896-2026 · Initiated March 25, 2026

    Recall

    Recall Number
    Z-1896-2026
    Event Number
    98602
    Firm
    Davol, Inc.
    FEI Number
    1213643
    Product Code
    LMF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 25, 2026
    Posted
    April 21, 2026
    Address
    100 Crossings Blvd, Warwick, RI, 02886-2850

    Description

    Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.

    Reason

    Potential for product to contain foreign matter, confirmed to be inspect fragments.

    Action

    Davol, Inc. (Subsidiary of C.R. Bard, Inc.) notified consignees on about 03/25/2026 via emailed and mailed letter. Consignees were instructed to immediately discontinue use of and destroy any affected products on hand, hold in quarantine if destruction is not immediately possible, and complete and return the provided Customer Response Form. Consignees were also instructed to share the notification with anyone who needs to be aware within your organization and forwarded to any organization where affected products have been transferred. If affected product was purchased from a distributor, contact that distributor directly for further instructions and credit resolution. Distributors were instructed to immediately discontinue use of and destroy any affected products on hand, hold in quarantine if destruction is not immediately possible, and complete and return the provided Distributor Response Form. Distributors were further instructed to identify all customers within their distribution network who may have purchased any of the affected product listed in the notification and to provide a copy of the provided customer letter to all customers who may have received the affected product to advise them of this recall notification on BD s behalf. BD will issue replacement for destroyed product of the specific lot number identified above to customers that purchased the affected product directly from BD, following receipt of the completed Customer Response Form. BD will implement appropriate corrective and preventive actions, as warranted, to reduce the risk of recurrence.

    Distribution

    Worldwide distribution - US Nationwide and the countries of China, South Korea.

    Quantity

    1,622 units