Datascope Corp. Recall 91642
Description: Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Datascope Corp. Recall 91642 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1232-2023 |
| Event ID | 91642 |
| Event Description | Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85 |
| Product Type | Devices |
| Distribution | Nationwide US distribution. Worldwide international distribution. |
| Quantity | 4502 (US); 4407 (OUS) |
| Recall Reason | Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted. |
| Device Classification | 20230315 |
| Device Code Info | Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449 All serialnumbers |
| Center Classification Date | 20230306 |
| Recall Initiation Date | 20230207 |
| Recalling Firm | Datascope Corp. |
| Initial Notification | Letter |
| Similar To |