Maquet Cardiovascular Us Sales, Llc recalls Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW…
- Recall date
- December 3, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0678-2020
- FDA classification
- Class II
- Brand / firm
- Maquet Cardiovascular Us Sales, Llc
- Sold / distributed
- The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.
Why it was recalled
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
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