Cardinal Health Recalls AAMI 3 Nonreinforced Surgical Gowns Due to Contamination
Cardinal Health is recalling AAMI 3 nonreinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
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: The recall involves a medical device with unknown contamination levels (bioburden and particulates) which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cardinal Health is recalling approximately 7.7 million units of AAMI 3 Nonreinforced Surgical Gowns (Item Code 9545NC). The recall is due to the presence of an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination in the gowns.
The affected products were distributed worldwide, including in the United States (nationwide, Puerto Rico, and Guam), the United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, the Dominican Republic, Israel, Mexico, Oman, Panama, the Philippines, and Saudi Arabia. The recall covers specific lot numbers manufactured in 2018 and 2019, identified by specific alphanumeric codes provided in the agency documentation.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for further instructions. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC
- Manufacturer
- Cardinal Health
- Category
- Medical Device — Surgical Gowns
- Affected units
- 7,659,634
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 (2)
- 244 or greater is affected OR " " If made in 2019
- any value is affected
Distribution
Part of a larger recall action
This product is one of 39 recalled by Cardinal Health 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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