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Copioumed
Copious International Inc. · Model IGN0B1084-1 · UDI-DI 04719882253386
0
510(k) clearances
42
Adverse events
18
Recalls
560
Facilities
Description
COPIOUMED Isolation gown is made of non-woven fabric and combined with materials with better permeability resistance as plastic film. It can cover the body and all clothing, forming a physical barrier to prevent the spread of substances such as microorganisms. To protect the safety of medical staff and avoid the secondary infection of patients.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-31 | New York Embroidery Studio, Inc. | Gowns do not consistently meet the minimum liquid-barrier performance required. |
| 2024-06-03 | Stryker Corporation | Expired Products distributed to customers |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
| 2021-01-07 | Cardinal Health 200, LLC | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. |
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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.