Recall Z-2635-2023— Fresenius Kabi USA, LLC

Name: FDA recall Z-2635-2023
Creator: U.S. Food and Drug Administration
Published: 2022-04-22

Class II · Ongoing

Class II FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2022-04-22. It names one FDA 510(k) clearance: K183311. Product: Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.. Reason: Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set.

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-04-22
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), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

Reason for recall

Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set

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