FDA recall Z-1423-2025

Baxter Healthcare Corporation · Class II · device

Product

Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS

Reason for recall

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.

Distribution

US Nationwide distribution in the states of AR, CA, FL, IA, IN, LA, MO, MT, NC, NY, OH, OR, PA, TN, TX, VA, WA, WI, WV.

Key facts

Status
Ongoing
Initiation date
2025-03-03
Report date
2025-04-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1423-2025