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U.S. Department of Health and Human Services

Class 2 Device Recall Ivenix Infusion System (IIS)

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  Class 2 Device Recall Ivenix Infusion System (IIS) see related information
Date Initiated by Firm April 22, 2022
Create Date July 13, 2022
Recall Status1 Terminated 3 on May 20, 2024
Recall Number Z-1381-2022
Recall Event ID 90314
510(K)Number K183311  
Product Classification Infusion safety management software - Product Code PHC
Product Ivenix Infusion System (IIS)
Code Information 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 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Recalling Firm/
Manufacturer		 Ivenix, Inc.
50 High St Ste 50
North Andover MA 01845-2620
For Additional Information Contact John Sokolowski
978-775-8030
Manufacturer Reason
for Recall		 Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
FDA Determined
Cause 2		 Software design
Action 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
Quantity in Commerce 1335 devices
Distribution US Nationwide distribution in the states of NJ and WI.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PHC and Original Applicant = Ivenix, Inc.
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