Z-0986-2019 Class I Terminated
FDA device recall Z-0986-2019 was initiated by Maquet Cardiovascular Us Sales, Llc on February 8, 2019 and is designated Class I. Reason for recall: 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. The recall status is terminated (terminated May 14, 2020). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- February 8, 2019
- Termination Date
- May 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.
Code Information
Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304