Fresenius Medical Care Holdings, Inc. Recall 89369
Description: 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,
Fresenius Medical Care Holdings, Inc. Recall 89369 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0562-2022 |
| Event ID | 89369 |
| Event Description | 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, |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IL, MI, NJ, NV, NY, OK, OR, PA, TN, TX, WV. |
| Quantity | 115 units |
| Recall Reason | 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. |
| Device Classification | 20220216 |
| Device Code Info | 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) |
| Center Classification Date | 20220204 |
| Recall Initiation Date | 20211207 |
| Recalling Firm | Fresenius Medical Care Holdings, Inc. |
| Initial Notification | Letter |
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