Fresenius Medical Care Holdings, Inc.: Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides ass

Hazard

Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.

Details from the source

Reason for recall: Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system. Distribution: US Nationwide distribution. Quantity: 88 units Lot/code info: UDI-DI: 4057224 (+ serial number) Serial Numbers:XCONUS0001 to XCONUS0124

Source

Official record: FDA (Device enforcement) ↗

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