Cardinal Health Recalls RoyalSilk Gowns Due to Unknown Contamination
Cardinal Health is recalling RoyalSilk XLARGE 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 is classified as FDA Class II and involves unknown contamination (bioburden, microbiological flora, particulate) in a medical device. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported' or high-risk pathogens without reported illness, warranting a score of 3.
Plain-English summary
Cardinal Health is recalling approximately 7.7 million units of ROYALSILK XLARGE gowns (Item Code 9548). The recall covers gowns manufactured in 2018 and 2019 that were distributed worldwide, including the United States, Puerto Rico, Guam, and various international markets.
The gowns are being recalled because they contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The source text does not specify the exact nature of the contaminants or the specific health risks associated with them.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ROYALSILK XLARGE, Gown. Item Code 9548
- 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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