Datascope Corp. Recall 88983
Description: Cardiosave Rescue Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449
Datascope Corp. Recall 88983 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0337-2022 |
| Event ID | 88983 |
| Event Description | Cardiosave Rescue Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide. |
| Quantity | 4,338 (US); 3,613 (OUS) |
| Recall Reason | Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability. |
| Device Classification | 20211222 |
| Device Code Info | All Unit Serial Numbers |
| Center Classification Date | 20211215 |
| Recall Initiation Date | 20211115 |
| Recalling Firm | Datascope Corp. |
| Initial Notification | Letter |
| Similar To |