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 |
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