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Cardinal Health Recall 89015

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

Cardinal Health Recall 89015 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0371-2022
Event ID89015
Event DescriptionSmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.
Quantity363,480 units
Recall ReasonPotential for open packaging seals compromising the sterility of the surgical gowns
Device Classification20211222
Device Code InfoLot 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)
Center Classification Date20211210
Recall Initiation Date20211102
Recalling FirmCardinal Health
Initial Notification Letter
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