Z-1822-2024 Class II Ongoing
FDA device recall Z-1822-2024 was initiated by Fresenius Medical Care Holdings, Inc. on Apr 8, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 88 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- Apr 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88 units
Product Description
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 respiratory failure or acute cardiopulmonary failure Product Code: F30000163
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 Pattern
US Nationwide distribution.
Code Information
UDI-DI: 4057224 (+ serial number) Serial Numbers:XCONUS0001 to XCONUS0124
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1822-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026