Home / Recalls / Cardinal Health 200, LLC / Z-0674-2025

Z-0674-2025 Class II Ongoing

Recalled by Cardinal Health 200, LLC — Waukegan, IL

Recall Details

Product Type
Devices
Report Date
December 18, 2024
Initiation Date
November 1, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
940,203 total units

Product Description

Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL

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 Pattern

US Nationwide. Canada, UAE

Code Information

All Lots. AT6100 UDI-DI: CS (01) 50192253048252 EA (01) 20192253048251; AT6100-XL UDI-DI: CS (01) 50192253048269 EA (01) 20192253048268; AT6200 UDI-DI: CS (01) 50192253048276 EA (01) 20192253048275; AT6200-XL UDI-DI: CS (01) 50192253048283 EA (01) 20192253048282

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