Surgical Gowns Recalled Due to Potential Packaging Seal Defects
Cardinal Health is recalling SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns (X-Large, SKU 9041) due to potential open packaging seals that could compromise sterility. The recall affects 231,219 units distributed worldwide.
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 3/5 (High).
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 FDA Class II device recall involves a medical device with potential sterility compromise but no reported illnesses or injuries. As a risk-of-harm product where injury has not yet been reported, it meets the High severity threshold.
Plain-English summary
Cardinal Health is recalling SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns in size X-Large (SKU 9041) due to potential for open packaging seals. Open seals could compromise the sterility of the surgical gowns, which is critical for safe use in medical and surgical settings.
The recall involves 231,219 units distributed worldwide, including US Nationwide and shipments to Canada, Chile, Thailand, Israel, and multiple Latin American locations. Multiple lot numbers from the 20MJQ and 21AJQ through 21JJQ series are affected. The UDI is 50885380172494 (case level) and 10885380172496 (each level).
Healthcare facilities and medical professionals who have received these gowns should stop use immediately and verify their lot numbers against the recall notice. Contact Cardinal Health for instructions on return, replacement, or proper disposal of affected gowns.
The recalled product
- Product
- SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
- Manufacturer
- Cardinal Health
- Category
- Medical Device — Surgical Gowns
- Affected units
- 231,219
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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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