Cardinal Health Recall 89015
Description: SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
Cardinal Health Recall 89015 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0371-2022 |
| Event ID | 89015 |
| Event Description | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL |
| 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 | 363,480 units |
| Recall Reason | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Device Classification | 20211222 |
| Device Code Info | Lot Numbers: 20MBQ001 21ABQ001 21ABQ002 21BBQ002 21BBQ003 21BBQ004 21BBQ005 21CBQ002 21CBQ003 21DBQ003 21DBQ004 21DBQ005 21EBQ003 21EBQ004 21EBQ005 21FBQ002 21FBQ003 21FBQ004 21FBQ005 21HBQ001 21HBQ002 21JBQ002 UDI: 50192253018996 (cs) 10192253018998 (ea) |
| Center Classification Date | 20211210 |
| Recall Initiation Date | 20211102 |
| Recalling Firm | Cardinal Health |
| Initial Notification | Letter |
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