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CARDINAL HEALTH

Cardinal Health 200, LLC · Model AT4488-BD · UDI-DI 20885380152303

OEA

510(k) clearances

Adverse events

Recalls

560

Facilities

Description

Isolation Gown Universal Size AAMI Level 2 Over-the-head With Thumbhooks and Elastic Wrists Yellow

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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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.