Device product
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Z-1689-2024
Product summary
- Event
- Event 94298
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 165 units
- Official record key
device-enforcement:Z-1689-2024
Official wording
Reason: Product was distributed in the United States without proper regulatory approval.
Code information: UDI/DI 05413765588310, Lot Number DBYSEP046
Distribution pattern: US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
Derived failure modes
-
Unknown
Product was distributed in the United States without proper regulatory approval.