FDAFDA · Food and drugs·Recall number Z-1689-2024
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Published May 1, 2024 · Recall initiated: March 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product was distributed in the United States without proper regulatory approval.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
- Lot
- UDI/DI 05413765588310, Lot Number DBYSEP046
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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