Cardinal Health Recalls ROYALSILK Gowns Due to Unknown Contamination
Cardinal Health is recalling 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by unknown bioburden/microbiological flora in medical devices) are rated Severe (4).
Plain-English summary
Cardinal Health is recalling ROYALSILK 2XLARGE gowns (Item Code 9578) because the products contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The recall involves 7,659,634 total units.
The affected gowns were distributed worldwide, including the United States (nationwide, Puerto Rico, and Guam), United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, 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 further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- ROYALSILK 2XLARGE, Gown. Item Code 9578
- 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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