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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly given the presence of unknown biological and particulate contamination in medical devices.
Plain-English summary
Cardinal Health is recalling approximately 7.7 million units of ROYALSILK 3XLARGE/XLONG gowns (Item Code 95998). The recall is being conducted because the gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
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 FDA has classified this as a Class II recall, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
- 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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