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PRIMED

priMED Medical Products Inc · Model PM4-67194 · UDI-DI 00842942007828

FME
5
510(k) clearances
7
Adverse events (1 deaths)
1
Recalls
237
Facilities

Description

Fluid Resistant Isolation Gown, Yellow, Polyethylene-Coated Psb, Full Back, Tie Closure, And Knit Cuff

Recalls

DateFirmReason
2009-12-23Encompass Group LLCThe products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.

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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.