Recall Z-1381-2022
Ivenix, Inc. · initiated April 22, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Ivenix Infusion System (IIS)
Codes / lots: UDI-DI: LVP-SW-0004 Software version 5.0 System serial numbers: 2118200011 2119300411 2119300414 2119300415 2119300417 2119300418 2119300421 2119300422 2119300423 2119300424 2119300425 2119300426 2119300427 2119300428 2119300429 2119300430 2119300431 2119300432 2119300434 2119300435 2119300436 2119300437 2119300438 2119300439 2119300440 2119300441 2119300442 2124300050 2124300051 2124300052 2124300055 2124300058 2124300062 2124300067 2124300068 2124300070 2124300073 2124300074 2124300076 2124300078 2124300079 2124300081 2124300082 2124300084 2124300086 2124300087 2124300088 2124300089 2124300090 2124300092 2124300094 2124300095 2124300096 2124300101 2124300102 2124300105 2124300123 2124300124 2124300127 2124300133 2124300137 2124300141 2124300130 2124300114 2124300140 2124300115 2124300129 2124300100 2124300109 2124300110 2118200008 2119300412 2119300416 2124300049 2124300053 2124300054 2124300056 2124300059 2124300060 2124300061 2124300064 2124300065 2124300066 2124300069 2124300071 2124300072 2124300075 2124300077 2124300080 2124300083 2124300085 2124300091 2124300093 2124300097 2124300104 2124300106 2124300107 2124300108 2124300112 2124300116 2124300118 2124300119 2124300120…
Reason for recall
Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
FDA-determined cause: Software design
Action taken
On April 22, 2022, the firm notified affected customers of the product issue through a letter titled "Important Safety Update." The firm is working on a software update to correct the issue. It will be available in approximately 60 days. The firm will inform customers when the update is ready to install. As interim corrections, the firm recommends that any pump that is infusing into the downstream access port have an infusion pressure less than 525 mm Hg. Alternatively, the Occlusion Retry Attempts in the Infusate Library Care Profile Pump Setting should be set to 0. Care profile pump settings are described in the Infusate Library and Pump Management Instructions for Use. If you have additional questions, please contact Customer Support: support@ivenix.com or 1-978-775-8100
Details
- Recall number
- Z-1381-2022
- Initiated
- April 22, 2022
- Terminated
- May 20, 2024
- Product code
- PHC – Infusion Safety Management Software
- Quantity
- 1335 devices
- Distribution
- US Nationwide distribution in the states of NJ and WI.
- Recalling firm
- Ivenix, Inc., North Andover, MA