Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels
Cardinal Health is recalling AAMI 3 ROYALSILK SURGGOWN BNS XL units worldwide due to 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 explicitly states no illnesses or injuries have been reported, 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 ROYALSILK SURGGOWN BNS XL surgical gowns. The recall covers units distributed worldwide, including the United States (including Puerto Rico and Guam), Canada, Australia, and several countries in the Middle East, South America, and Asia.
The recall was initiated because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The source text does not specify the exact cause of the contamination or the specific lot numbers affected, though it notes that the issue relates to production during specific periods in 2018 and 2019.
Healthcare facilities and consumers should stop using these gowns and contact Cardinal Health for instructions on return or disposal. The source text does not report any specific illnesses or injuries associated with the use of these products.
The recalled product
- Product
- AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
- 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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