Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
This recall is currently active, issued April 25, 2024. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- March 15, 2024
- Posted
- April 25, 2024
- Recall Number
- Z-1689-2024
- Quantity
- 165 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Product was distributed in the United States without proper regulatory approval.
Distribution
US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
Lot / Code Info
UDI/DI 05413765588310, Lot Number DBYSEP046
Root Cause
Under Investigation by firm
Action Taken
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.