Baxter Seprafilm Adhesion Barrier Recalled for Unapproved Distribution
Baxter Healthcare is recalling Seprafilm Adhesion Barrier units (165 units, Lot DBYSEP046) that were distributed nationwide without FDA approval. Affected units distributed in LA, GA, IN, VA, FL, NY, and CA.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II device recalled due to regulatory non-compliance—the product was distributed without proper FDA approval. The recall is based on regulatory non-compliance rather than on reported adverse events.
Plain-English summary
Baxter Healthcare Corporation is recalling Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-pack (REF 664103, Lot Number DBYSEP046). This surgical device is used as an adhesion barrier in abdominal and pelvic surgical procedures.
The product was distributed in the United States without obtaining proper regulatory approval from the FDA. A total of 165 units were affected by this distribution.
The recalled product was distributed nationwide in the states of Louisiana, Georgia, Indiana, Virginia, Florida, New York, and California.
The recalled product
- Product
- Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 165
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 05413765588310
- Lot Number DBYSEP046
Distribution
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