Product Safety Recalls

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Cardinal Health Recall 89015

Description: RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Cardinal Health Recall 89015 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0375-2022
Event ID89015
Event DescriptionRoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
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.
Quantity364,481 units
Recall ReasonPotential for open packaging seals compromising the sterility of the surgical gowns
Device Classification20211222
Device Code InfoLot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea)
Center Classification Date20211210
Recall Initiation Date20211102
Recalling FirmCardinal Health
Initial Notification Letter
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