PlainRecalls
FDA Devices Moderate Class II Ongoing

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011

Reported: December 22, 2021 Initiated: November 2, 2021 #Z-0369-2022

Product Description

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011

Reason for Recall

Potential for open packaging seals compromising the sterility of the surgical gowns

Details

Recalling Firm
Cardinal Health
Units Affected
169,262 units
Distribution
Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled?
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011. Recalled by Cardinal Health. Units affected: 169,262 units.
Why was this product recalled?
Potential for open packaging seals compromising the sterility of the surgical gowns
Which agency issued this recall?
This recall was issued by the FDA Devices on December 22, 2021. Severity: Moderate. Recall number: Z-0369-2022.