Recall Z-1689-2024 ยท MCN Barrier, Absorbable, Adhesion
Baxter Healthcare Corporation
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
| Date | Apr 25, 2024 (initiated Mar 15, 2024) |
| Status | Open, Classified |
| Reason | Product was distributed in the United States without proper regulatory approval. |
| Root cause | Under Investigation by firm |
| 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. |
| Quantity | 165 units |
| Distribution | US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.