Reported Dec 18, 2024 · Ongoing
Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD,…
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?
- 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
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 5088538016663920885380166638CS (01) 50885380166639 EA (01) 20885380166638 2 5088538016664620885380166645AT6588-BD UDI-DI: CS (01) 50885380166646 EA (01) 20885380166645 3 5088538016665320885380166652AT6588-XL UDI-DI: CS (01) 50885380166653 EA (01) 20885380166652 4 5088538016666020885380166669AT6688-2XL UDI-DI: CS (01) 50885380166660 EA (01) 20885380166669 5 5088538016667720885380166676AT6688-BD UDI-DI: CS (01) 50885380166677 EA (01) 20885380166676 6 5088538016668420885380166683AT6688-XL UDI-DI: CS (01) 50885380166684 EA (01) 20885380166683 - 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Cardinal Health 200, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.