Convertor Isolation Gowns may fail protective barrier requirements
Cardinal Health is recalling 940,203 Convertor Isolation Gowns because raw materials may prevent them from meeting AAMI Level 3 protection specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is theoretical—gowns may fail to meet hydrostatic pressure specifications—fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Convertor Isolation Gowns (Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL) because raw materials used in manufacturing may not meet required specifications.
The gowns may fail the hydrostatic pressure test, meaning they would not comply with AAMI Level 3 protection requirements. This could compromise their intended barrier protection.
The recall affects 940,203 units distributed throughout the United States, Canada, and the United Arab Emirates. All lots of the listed product codes are included.
The recalled product
- Product
- Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 940,203
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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