Baxter recalls 5-pack of Seprafilm Adhesion Barrier 1 Half Sheets (REF 664103) for abdominal/pelvic surgery due to lack of U.S. regulatory approval. Affected units include specific lot numbers and UDI/DI codes.
Product was distributed in the United States without proper regulatory approval.
Baxter is recalling a 5-pack of Seprafilm Adhesion Barrier 1 Half Sheets used in abdominal and pelvic surgery because they were distributed in the U.S. without proper regulatory approval. This means the product may not meet safety standards for surgical use.
The product was distributed in the U.S. without proper regulatory approval, meaning it may not meet safety standards for surgical use. This could lead to complications during procedures if the product does not function as intended.
Surgical patients and healthcare providers who used or received the Baxter Seprafilm Adhesion Barrier 1 Half Sheets (5-PK, REF 664103) for abdominal or pelvic surgery. Those with the specific lot number DBYSEP046 or UDI/DI 05413765588310 are most at risk.
Check for the product name 'Seprafilm Adhesion Barrier 1 Half Sheet', 5-pack, REF 664103. Look for the lot number DBYSEP046 or UDI/DI code 05413765588310 on the packaging.
Verify the product name, lot number, and UDI/DI code to confirm if it matches the recalled items.
The product was distributed in the United States without proper regulatory approval.
The recall record does not specify a remedy, so check the product details to confirm if it matches the recalled items.
Look for the product name 'Seprafilm Adhesion Barrier 1 Half Sheet', 5-pack, REF 664103 with lot number DBYSEP046 or UDI/DI code 05413765588310.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-1689-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-1689-2024 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
