SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
Check against the official notice below — it lists the full affected range.
Cardinal Health is recalling 231,219 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns in X-Large size due to potential for open packaging seals that could compromise the sterility of the gowns. The affected products were distributed worldwide, including throughout the United States and in Chile, Thailand, Canada, Israel, Qatar, Panama, Mexico, Colombia, and Costa Rica. The recall affects multiple lot numbers from 2020 and 2021.
The recalled gowns are identified by specific lot numbers beginning with "20MJQ" or "21" followed by various letter and number combinations, with UDI codes 50885380172494 (case level) and 10885380172496 (each level). The recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for open packaging seals compromising the sterility of the surgical gowns
Reason for recall: Potential for open packaging seals compromising the sterility of the surgical gowns 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. Quantity: 231,219 units Lot/code info: Lot Numbers: 20MJQ001 20MJQ002 21AJQ001 21AJQ002 21AJQ003 21AJQ004 21AJQ005 21AJQ006 21BJQ001 21BJQ002 21CJQ001 21DJQ001 21DJQ002 21DJQ003 21EJQ001 21EJQ002 21EJQ003 21EJQ004 21FJQ001 21FJQ002 21FJQ003 21GJQ001 21GJQ002 21HJQ001 21HJQ002 21HJQ003 21HJQ004 21HJQ005 21HJQ006 21JJQ001 21JJQ002 21JJQ003 UDI: 50885380172494 (cs) 10885380172496 (ea)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.