Baxter Healthcare Corporation Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
UDI/DI 05413765588310, Lot Number DBYSEP046
Products Sold
UDI/DI 05413765588310, Lot Number DBYSEP046
Baxter Healthcare Corporation is recalling Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic su due to Product was distributed in the United States without proper regulatory approval.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product was distributed in the United States without proper regulatory approval.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026