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Seprafilm® 4-section
GENZYME CORPORATION · Model 6380-01 · UDI-DI 00358468638014
MCN
Prescription
0
510(k) clearances
1,558
Adverse events (30 deaths)
3
Recalls
20
Facilities
Description
Barrier, Absorbable, Adhesion
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-15 | Baxter Healthcare Corporation | Product was distributed in the United States without proper regulatory approval. |
| 2012-06-13 | Genzyme Corporation | Sterility of product may be compromised due to packaging defect |
| 2012-06-13 | Genzyme Corporation | Sterility of product may be compromised due to packaging defect |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.