Class II

Medical Device Recall: Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL

Cardinal Health 200, LLC · November 1, 2024

Reason for Recall

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.

Distribution

US Nationwide. Canada, UAE

States Affected

NATIONWIDE

Quantity Affected

940,203 total units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0674-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Cardinal Health 200, LLC Medical Device Recall: Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL | SafeCheck