Cardinal Health RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise
Cardinal Health has recalled RoyalSilk Non-Reinforced Surgical Gowns XX-large due to the potential for packaging seals to open, which could compromise product sterility. The recall affects approximately 9,990 units distributed worldwide.
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: This Class II medical device recall involves a potential hazard to product sterility that could affect patient safety, but no illnesses or injuries have been reported. It meets the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cardinal Health has issued a Class II recall of RoyalSilk Non-Reinforced Surgical Gowns XX-large (SKU 9578) due to the potential for packaging seals to open during storage or transport, which could compromise the sterility of the surgical gowns.
The recalled products include approximately 9,990 units with lot numbers 20MLQ001, 21BLQ001, 21CLQ001, 21DLQ001, 21DLQ002, 21ELQ001, 21ELQ002, 21ELQ003, 21GLQ001, and 21HLQ001. The products have been distributed worldwide, including the United States and select international locations (Chile, Thailand, Canada, Israel, Qatar, and other Latin American countries).
Healthcare facilities and users who have received these gowns should verify their lot numbers against the recall list. Do not use gowns from affected lots. Contact Cardinal Health for instructions on returning recalled products or obtaining replacement sterile gowns. The FDA has not received reports of injury or illness related to this recall.
The recalled product
- Product
- RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578
- Manufacturer
- Cardinal Health
- Category
- Medical Device — Surgical Gowns
- Hazard
- open-packaging-seal
- sterility-compromise
Distribution
Distributed nationwide across the United States.
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