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Cardinal Health Recall 89015

Description: RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548

Cardinal Health Recall 89015 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0376-2022
Event ID89015
Event DescriptionRoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
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.
Quantity270,839 units
Recall ReasonPotential for open packaging seals compromising the sterility of the surgical gowns
Device Classification20211222
Device Code InfoLot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (ea)
Center Classification Date20211210
Recall Initiation Date20211102
Recalling FirmCardinal Health
Initial Notification Letter
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