Cardinal Health Recall 89015
Description: RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Cardinal Health Recall 89015 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0375-2022 |
Event ID | 89015 |
Event Description | RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518 |
Product Type | Devices |
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 | 364,481 units |
Recall Reason | Potential for open packaging seals compromising the sterility of the surgical gowns |
Device Classification | 20211222 |
Device Code Info | Lot 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 Date | 20211210 |
Recall Initiation Date | 20211102 |
Recalling Firm | Cardinal Health |
Initial Notification | Letter |
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