Recall Z-1689-2024— Baxter Healthcare Corporation
Class II · Ongoing
Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-03-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-15
- Firm location
- Deerfield, IL, United States
Product description
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Reason for recall
Product was distributed in the United States without proper regulatory approval.
Data sourced from openFDA. This site is unofficial and independent of the FDA.