Reported Dec 18, 2019 · Terminated
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW…
Maquet Cardiovascular US Sales, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
- Lot codes and dates
- UDI04037691258997; Serial Numbers
93489369101144129101144209101144299101144309101144329101144359101144389101172439106472291067680
- UDI04037691258997; Serial Numbers
- Amount recalled
- 11 distributed in the US
Where it was sold
Why it was recalled
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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