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HCS Sourcing

Concordance Healthcare Solutions LLC · Model 3004OTCB2XL · UDI-DI 00810132044366

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

Description

Gown, Isolation XL, AAMI Rated Level 2, Yellow. SMS Material, Over the Head Neck, Waist Tie and Thumbloop Cuff

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.