FDA Medical devices recall ·
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100… recall
- Recall number
- Z-0674-2025
- Date
- (initiated November 1, 2024)
- Company / brand
- Cardinal Health 200, LLC
3651 Birchwood Dr, Waukegan, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 940,203 total units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide. Canada, UAE
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0674-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.