BEUDAMED
    FDA Recall Open, Classified

    Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery

    Recall: Z-1689-2024 · Initiated March 15, 2024

    Recall

    Recall Number
    Z-1689-2024
    Event Number
    94298
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    MCN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 15, 2024
    Posted
    April 25, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery

    Reason

    Product was distributed in the United States without proper regulatory approval.

    Action

    Baxter issued an Urgent Medical Device Recall notice to its consignee on 03/15/2024 via USPS, first class mail. The notice explained the issue, hazard, and requested the following: Immediately locate, isolate, and cease all use of the affected lot number of the product. . Baxter Healthcare will contact impacted customers to arrange for replacement product, return, and credit. If additional support is needed, customers can contact Baxter Healthcare Center for Service.

    Distribution

    US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.

    Quantity

    165 units