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Tronex International, Inc.
TRONEX INTERNATIONAL, INC. · Model MLN94535Y · UDI-DI 10097604945353
10
510(k) clearances
28
Adverse events
2
Recalls
56
Facilities
Description
Gown, Isolation, Multilayer, AAMI Level 3, Tape-Tab Neck , Elastic Cuffs, Fluid Resistant, Latex-Free, Yellow, Extra-Large
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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