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Datascope Corp. recalls Cardiosave Rescue. Model Number: 0998-00-0800-83.
Recalled March 15, 2023 · FDA recall Z-1232-2023 · Datascope
Hazard
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. · FDA Class II
Units
47 units (44 US, 3 OUS)
Sold at
Nationwide US distribution. Worldwide international distribution.
Description
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.
Product
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Manufacturer(s)
Datascope Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →