Recall Z-1313-2023— Fresenius Kabi USA, LLC

Name: FDA recall Z-1313-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-10

Class I · Ongoing

Class I FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2023-03-10. It names one FDA 510(k) clearance: K183311. Product: Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004. Reason: Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion..

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class I
Status: Ongoing
Initiated: 2023-03-10
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, Model No. LVP-0004

Reason for recall

Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.

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