Class II

Medical Device Recall: Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-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-0675-2025

Status: ongoing

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