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Ivenix, Inc. Recall 90314

Description: Ivenix Infusion System (IIS)

Ivenix, Inc. Recall 90314 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1381-2022
Event ID90314
Event DescriptionIvenix Infusion System (IIS)
Product TypeDevices
DistributionUS Nationwide distribution in the states of NJ and WI.
Quantity1335 devices
Recall ReasonDownstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
Device Classification20220720
Device Code InfoUDI-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 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Center Classification Date20220713
Recall Initiation Date20220422
Recalling FirmIvenix, Inc.
Initial Notification Letter
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