Recall Z-1381-2022— Ivenix, Inc.

Name: FDA recall Z-1381-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-22

Class II · Terminated

Class II FDA medical device recall by Ivenix, Inc., initiated 2022-04-22, terminated 2024-05-20. It names one FDA 510(k) clearance: K183311. Product: Ivenix Infusion System (IIS). Reason: Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm..

Recalling firm: Ivenix, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-04-22
Terminated: 2024-05-20
Firm location: North Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K183311 — Ivenix Infusion System (IIS)Ivenix, Inc.·cleared 2019-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ivenix Infusion System (IIS)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.