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Cardinal Health 200, LLC recalls Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Recalled December 18, 2024 · FDA recall Z-0674-2025 · Cardinal Health 200
Hazard
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. · FDA Class II
Units
940,203 total units
Sold at
US Nationwide. Canada, UAE
Description
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.
Product
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Manufacturer(s)
Cardinal Health 200, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →