Cardinal Health isolation gowns recalled for failing hydrostatic pressure standards
Cardinal Health is recalling 940,203 SMS Elastic Cuff Thumbhook Level 3 Isolation Gowns because the raw materials may fail hydrostatic pressure specifications, preventing them from meeting required AAMI Level 3 protection standards.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II medical device recall involving protective equipment that may fail to meet required liquid barrier protection standards. No illnesses or injuries have been reported, making this a risk-of-harm product where harm has not yet been documented, consistent with the rubric criterion for Score 3.
Plain-English summary
Cardinal Health 200, LLC is recalling 940,203 SMS Elastic Cuff Thumbhook Level 3 Isolation Gowns, Full-Back. The affected product codes are AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL. All lots of these isolation gowns are included in this recall.
The gowns were manufactured with raw materials that may fail the hydrostatic pressure specification. This means they may not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements, which specify the liquid barrier capability that healthcare workers rely on when wearing these gowns.
The recalled gowns were distributed nationwide in the United States as well as in Canada and the United Arab Emirates. Healthcare facilities should stop using the affected products and contact Cardinal Health to arrange replacement or return of the recalled gowns.
The recalled product
- Product
- 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
- 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 (6)
- 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
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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