Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
FDA device recall Z-1689-2024 · posted 2024-04-25 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- Reason for recall
- Product was distributed in the United States without proper regulatory approval.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MCN
- Quantity affected
- 165 units
- Distribution
- US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
- Date initiated
- 2024-03-15
- Date posted
- 2024-04-25
- Location
- Deerfield, IL
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