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

Class I - Dangerous

🏥 Medical Devices Recalled: November 1, 2024 Cardinal Health 200 Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Cardinal Health 200, LLC
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0674-2025

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Class I - Dangerous

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Cardinal Health 200

Class I - Dangerous

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