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FDA (Device enforcement)Recalled 2021-11-02class ii

Cardinal Health: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL

Is my product affected?

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL

  • UPC 50192253018996
  • UPC 10192253018998

Check against the official notice below — it lists the full affected range.

What happened

Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns in X-large, X-long size because the packaging seals may be open, which could compromise the sterility of the gowns. The affected gowns were distributed worldwide, including throughout the United States and in Chile, Thailand, Canada, Israel, and various Latin American countries. The recall involves specific lot numbers ranging from 20MBQ001 through 21JBQ002.

The source record does not specify a remedy for affected consumers or what actions they should take regarding the recalled gowns.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 363,480 units Lot/code info: Lot Numbers: 20MBQ001 21ABQ001 21ABQ002 21BBQ002 21BBQ003 21BBQ004 21BBQ005 21CBQ002 21CBQ003 21DBQ003 21DBQ004 21DBQ005 21EBQ003 21EBQ004 21EBQ005 21FBQ002 21FBQ003 21FBQ004 21FBQ005 21HBQ001 21HBQ002 21JBQ002 UDI: 50192253018996 (cs) 10192253018998 (ea)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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