FDA recall Z-0678-2020

Maquet Cardiovascular Us Sales, Llc · Class II · device

Product

Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

Reason for recall

A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.

Distribution

The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.

Key facts

Status
Terminated
Initiation date
2019-12-03
Report date
2019-12-18
Termination date
2020-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0678-2020