Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Ivenix Infusion System (IIS)

FDA Recall Z-1381-2022 · Posted None

Recalling FirmIvenix, Inc.
Recall StatusTerminated
Product CodePHC
Date Initiated2022-04-22
Date Terminated2024-05-20
Product Quantity1335 devices

Reason for Recall

Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.

Firm 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: [email protected] or 1-978-775-8100

Root Cause

Software design

Distribution Pattern

US Nationwide distribution in the states of NJ and WI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑