Home › COPIOUMED INTERNATIONAL INC. › Copioumed
Copioumed
COPIOUMED INTERNATIONAL INC. · Model CTN3B304-1 · UDI-DI 04719882251771
1
510(k) clearances
34
Adverse events
2
Recalls
56
Facilities
Description
Copioumed Chemotherapy Isolation Gown is a disposable device intended to protect health care personal from exposure to chemotherapy drugs during preparation, handling and administration. This device is non-sterile and for single use only.
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 |
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 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.