Product Safety Recalls

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Cardinal Health Recall 89015

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

Cardinal Health Recall 89015 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0369-2022
Event ID89015
Event DescriptionSmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
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.
Quantity169,262 units
Recall ReasonPotential for open packaging seals compromising the sterility of the surgical gowns
Device Classification20211222
Device Code InfoLot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50885380172500 (cs) 10885380172502 (ea)
Center Classification Date20211210
Recall Initiation Date20211102
Recalling FirmCardinal Health
Initial Notification Letter
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