Reported Dec 18, 2024 · Ongoing
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
Convertor Isolation GownAAMI Level 3 protectionProduct Codes AT6100AT6100-XLAT6200and AT6200-XL
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 5019225304825220192253048251CS (01) 50192253048252 EA (01) 20192253048251 2 5019225304826920192253048268AT6100-XL UDI-DI: CS (01) 50192253048269 EA (01) 20192253048268 3 5019225304827620192253048275AT6200 UDI-DI: CS (01) 50192253048276 EA (01) 20192253048275 4 5019225304828320192253048282AT6200-XL UDI-DI: CS (01) 50192253048283 EA (01) 20192253048282 - Amount recalled
- 940,203 total units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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