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PRIMED
priMED Medical Products Inc · Model PM4-57493 · UDI-DI 00842942015304
10
510(k) clearances
28
Adverse events
2
Recalls
56
Facilities
Description
AAMI 3 Gown, Yellow, Universal
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-01 | Cardinal Health 200, LLC | Isolation 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 |
| 2024-11-01 | Cardinal Health 200, LLC | Isolation 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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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.