FDA-Device2019-12-18Class II
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Maquet Cardiovascular Us Sales, Llc
Hazard
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Sold states
The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.
Affected count
11 distributed in the US
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0678-2020Don't want to check this manually?
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