FDA recall Z-1232-2023

Product

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

Nationwide US distribution. Worldwide international distribution.

Key facts

Status

Ongoing

Initiation date

2023-02-07

Report date

2023-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1232-2023