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

Is my product affected?

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

• UPC 04037691258997

Check against the official notice below — it lists the full affected range.

What happened

Maquet Cardiovascular US Sales, LLC is recalling the ROTAFLOW Drive, Model Number 701022161, which is a component of the ROTAFLOW System Console. The hazard is that a loose ODU plug or coaxial cable connection may cause flow values displayed on the Console to fluctuate. Eleven units were distributed across seven US states: Maine, Nevada, New York, Ohio, Pennsylvania, Texas, and Virginia.

The affected devices can be identified by UDI 04037691258997 and the following serial numbers: 9348936, 910114412, 910114420, 910114429, 910114430, 910114432, 910114435, 910114438, 910117243, 91064722, and 91067680. The source document does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Quantity: 11 distributed in the US Lot/code info: UDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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