FDAFDA · Food and drugs·Recall number Z-0675-2025
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL
Published December 18, 2024 · Recall initiated: November 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health 200, LLC
- Distributor
- US Nationwide. Canada, UAE
- Lot
- All lots. AT6588-2XL UDI-DI: CS (01) 50885380166639 EA (01) 20885380166638; AT6588-BD UDI-DI: CS (01) 50885380166646 EA (01) 20885380166645; AT6588-XL UDI-DI: CS (01) 50885380166653 EA (01) 20885380166652; AT6688-2XL UDI-DI: CS (01) 50885380166660 EA (01) 20885380166669; AT6688-BD UDI-DI: CS (01) 50885380166677 EA (01) 20885380166676; AT6688-XL UDI-DI: CS (01) 50885380166684 EA (01) 20885380166683
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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