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MediChoice

OWENS & MINOR DISTRIBUTION, INC. · Model 77753XL · UDI-DI 30885632100301

FYC
10
510(k) clearances
28
Adverse events
2
Recalls
56
Facilities

Description

Gown Isolation Aami Level 3 Sms Full Back Elastic Cuff Tie Neck And Waist Yellow Xl Not Made With Natural Rubber Latex MediChoice

Recalls

DateFirmReason
2024-11-01Cardinal Health 200, LLCIsolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancem
2024-11-01Cardinal Health 200, LLCIsolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancem

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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.