Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Convertor Isolation Gown Recalled by Cardinal Health 200, LLC Due to Isolation Gowns were manufactured with raw materials that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cardinal Health 200, LLC directly.
Affected Products
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Quantity: 940,203 total units
Why Was This Recalled?
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 Advancement of Medical Instrumentation) Level 3 protection requirements.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cardinal Health 200, LLC
Cardinal Health 200, LLC has 275 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report