Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1822-2024 — Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute res

U.S. FDA — Device Enforcement · United States · 2024-04-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1822-2024
Date of alert: 2024-04-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Fresenius Medical Care Holdings, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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