Baxter Seprafilm Adhesion Barrier 1 Half Sheet recall
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Why was Baxter Seprafilm Adhesion Barrier 1 Half Sheet recalled?
Product was distributed in the United States without proper regulatory approval.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 05413765588310, Lot Number DBYSEP046
- Product
- Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 165 units
- Distribution
- US Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.
- Recall date
- May 1, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)