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Tronex International, Inc.

TRONEX INTERNATIONAL, INC. · Model 6333CHEMO35 · UDI-DI 10097604633342

OEA
0
510(k) clearances
42
Adverse events
17
Recalls
558
Facilities

Description

Gown, Chemotherapy Rated, Isolation, Multilayer Spunbond, Knitted Cuffs, Fluid Impervious, Latex-Free, Blue, Extra-Large

Recalls

DateFirmReason
2024-06-03Stryker CorporationExpired Products distributed to customers
2021-01-07Cardinal Health 200, LLCThere is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
2021-01-07Cardinal Health 200, LLCThere is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
2021-01-07Cardinal Health 200, LLCThere is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
2021-01-07Cardinal Health 200, LLCThere is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
2021-01-07Cardinal Health 200, LLCThere is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
2021-01-07Cardinal Health 200, LLCThere is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
2021-01-07Cardinal Health 200, LLCThere is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
2021-01-07Cardinal Health 200, LLCThere is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.
2021-01-07Cardinal Health 200, LLCThere 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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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.