Reported Feb 16, 2022 · Ongoing
Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours)…
Fresenius Medical Care Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 950 · Waltham, MA · 02451-1521
Is this the product you have?
- Novalung Sensor Box (F30000163) a component of 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, where other available treatment options have failed,
- Lot codes and dates
- Serial Numbers
112 of 112 codes
XCONUS0013XCONUS0079XCONUS0105XCONUS0036XCONUS0044XCONUS0004XCONUS0014XCONUS0080XCONUS0109XCONUS0021XCONUS0066XCONUS0027XCONUS0017XCONUS0084XCONUS0061XCONUS0043XCONUS0089XCONUS0059XCONUS0019XCONUS0085XCONUS0051XCONUS0047XCONUS0005XCONUS0042XCONUS0020XCONUS0086XCONUS0110XCONUS0055XCONUS0010XCONUS0083XCONUS0022XCONUS0087XCONUS0111XCONUS0064XCONUS0053XCONUS0121XCONUS0023XCONUS0088XCONUS0112XCONUS0002XCONUS0056XCONUS0018XCONUS0024XCONUS0090XCONUS0113XCONUS0003XCONUS0006XCONUS0054XCONUS0030XCONUS0091XCONUS0115XCONUS0007XCONUS0052XCONUS0081XCONUS0032XCONUS0094XCONUS0116XCONUS0012XCONUS0073XCONUS0008
- XCONUS0033 XCONUS0037 XCONUS0016 UDIPrefix: 4057224 (+ serial number)
- Serial Numbers
- Amount recalled
- 115 units
Where it was sold
Why it was recalled
Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.
This product could cause temporary or reversible health problems — stop using it.
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