FDA-Device2019-04-03Class I
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Maquet Cardiovascular Us Sales, Llc
Hazard
Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.
Sold states
US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.
Affected count
10
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0986-2019Don't want to check this manually?
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