FDA-Device2023-03-15Class II
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Datascope Corp.
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.
Sold states
Nationwide US distribution. Worldwide international distribution.
Affected count
47 units (44 US, 3 OUS)
Manufactured in
1300 Macarthur Blvd, Mahwah, NJ, United States
Products
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1232-2023Don't want to check this manually?
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