Cardinal Health Recall 89015
Description: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Cardinal Health Recall 89015 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0369-2022 |
| Event ID | 89015 |
| Event Description | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 |
| 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 | 169,262 units |
| Recall Reason | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Device Classification | 20211222 |
| Device Code Info | Lot 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 Date | 20211210 |
| Recall Initiation Date | 20211102 |
| Recalling Firm | Cardinal Health |
| Initial Notification | Letter |
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