Cardinal Health Recalls Royalsilk Gowns Due to Unknown Contamination
Cardinal Health is recalling approximately 7.7 million Royalsilk gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves unknown microbiological and particulate contamination in sterile medical devices, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Cardinal Health is recalling approximately 7,659,634 units of Royalsilk Large Gowns (Item Code 9518). 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, with facility code 'J'.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for instructions on how to return or dispose of the product.
The recalled product
- Product
- ROYALSILK LARGE, Gown. Item Code 9518
- 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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