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U.S. Department of Health and Human Services

Class 2 Device Recall Novalung

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 Class 2 Device Recall Novalungsee related information
Date Initiated by FirmDecember 07, 2021
Create DateFebruary 04, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0562-2022
Recall Event ID 89369
510(K)NumberK191407 
Product Classification Extracorporeal system for long-term respiratory / cardiopulmonary failure - Product Code QJZ
ProductNovalung 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,
Code Information Serial Numbers: XCONUS0013 XCONUS0079 XCONUS0105 XCONUS0036 XCONUS0044 XCONUS0004 XCONUS0014 XCONUS0080 XCONUS0109 XCONUS0021 XCONUS0066 XCONUS0027 XCONUS0017 XCONUS0084 XCONUS0061 XCONUS0043 XCONUS0089 XCONUS0059 XCONUS0019 XCONUS0085 XCONUS0051 XCONUS0047 XCONUS0005 XCONUS0042 XCONUS0020 XCONUS0086 XCONUS0110 XCONUS0055 XCONUS0010 XCONUS0083 XCONUS0022 XCONUS0087 XCONUS0111 XCONUS0064 XCONUS0053 XCONUS0121 XCONUS0023 XCONUS0088 XCONUS0112 XCONUS0002 XCONUS0056 XCONUS0018 XCONUS0024 XCONUS0090 XCONUS0113 XCONUS0003 XCONUS0006 XCONUS0054 XCONUS0030 XCONUS0091 XCONUS0115 XCONUS0007 XCONUS0052 XCONUS0081 XCONUS0032 XCONUS0094 XCONUS0116 XCONUS0012 XCONUS0073 XCONUS0008 XCONUS0039 XCONUS0095 XCONUS0118 XCONUS0070 XCONUS0009 XCONUS0040 XCONUS0096 XCONUS0025 XCONUS0072 XCONUS0001 XCONUS0049 XCONUS0092 XCONUS0026 XCONUS0075 XCONUS0011 XCONUS0058 XCONUS0093 XCONUS0028 XCONUS0082 XCONUS0045 XCONUS0067 XCONUS0097 XCONUS0122 XCONUS0048 XCONUS0065 XCONUS0068 XCONUS0098 XCONUS0123 XCONUS0063 XCONUS0029 XCONUS0069 XCONUS0099 XCONUS0124 XCONUS0031 XCONUS0035 XCONUS0074 XCONUS0100 XCONUS0034 XCONUS0071 XCONUS0046 XCONUS0076 XCONUS0102 XCONUS0038 XCONUS0060 XCONUS0050 XCONUS0077 XCONUS0103 XCONUS0041 XCONUS0062 XCONUS0015 XCONUS0078 XCONUS0104 XCONUS0033 XCONUS0037 XCONUS0016 UDI: Prefix: 4057224 (+ serial number)
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St Bld 950
Waltham MA 02451-1521
For Additional Information ContactSAME
781-6999580
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionFresenius Medical Care issued Urgent Medical Device Correction Letter ( Novalung Sensor Box P/N F30000163 FA-2021-33-C) on 12/7/21 via USPS First Class Mail. Letter sates reason for recall, health risk and action to take: In the rare event 206/208 alarms occur, you may silence the alarms intermittently using the audio pause button. If you have continued alarms, it is recommended to replace either the sensor box or the entire console if a secondary or backup sensor box is available. Reference section 6.2 of the Instructions for Use (Part Number US (Part Number US-003-2019-08). If available, switch to a backup sensor box. To correct this issue, FMCRTG will update the sensor box on your Novalung console. An FMCRTG Field Service Technician will be contacting you to schedule this correction. For questions or concerns, please contact your local sales representative or FMCRTG Technical Support Services at 800-405-1321.
Quantity in Commerce115 units
DistributionUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, PA, TN, TX, WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QJZ
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