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Gelfilm

PHARMACIA & UPJOHN COMPANY LLC · Model Gelfilm® Sterile Film Sterile film 1's (125 sq cm) · UDI-DI 10300090283015

OOD Prescription
10
510(k) clearances
1,213
Adverse events (7 deaths)
1
Recalls
12
Facilities

Description

Anti-adhesion dressing, bioabsorbable

Recalls

DateFirmReason
2016-11-21Tepha IncorporatedEndotoxin values from testing of retains slightly exceeded the established specification.

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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.