FDAFDA · Food and drugs·Recall number Z-0678-2020
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Published December 18, 2019 · Recall initiated: December 3, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Distributor
- The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.
- Lot
- UDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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