Cardinal Health 200, LLC recalls Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT65…

Recall date

November 1, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0675-2025

FDA classification

Class II

Brand / firm

Cardinal Health 200, LLC

Sold / distributed

US Nationwide. Canada, UAE

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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