Z-1232-2023 Class II Ongoing
FDA device recall Z-1232-2023 was initiated by Datascope Corp. on February 7, 2023 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 47 units (44 US, 3 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- March 15, 2023
- Initiation Date
- February 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 units (44 US, 3 OUS)
Product Description
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Reason for Recall
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.
Distribution Pattern
Nationwide US distribution. Worldwide international distribution.
Code Information
Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.