FDA Device Intelligence
HomeBAXTER HEALTHCARE CORPORATION › SEPRAFILM

SEPRAFILM

BAXTER HEALTHCARE CORPORATION · Model 508602 · UDI-DI 05413765589652

MCN Prescription
0
510(k) clearances
1,558
Adverse events (30 deaths)
3
Recalls
20
Facilities

Description

Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC).

Recalls

DateFirmReason
2024-03-15Baxter Healthcare CorporationProduct was distributed in the United States without proper regulatory approval.
2012-06-13Genzyme CorporationSterility of product may be compromised due to packaging defect
2012-06-13Genzyme CorporationSterility of product may be compromised due to packaging defect

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.