Baxter Novum IQ Syringe Pump Software Issue Recall
Baxter Healthcare is recalling 14,601 Novum IQ Syringe Pumps due to a software issue that may occur during multi-syringe infusions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with a potential software hazard where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling 14,601 units of the Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS. The recall is due to a software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
The affected devices were distributed nationwide in the United States, including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The recall includes all serial numbers associated with UDI-DI 05413765852428.
Healthcare facilities should contact Baxter Healthcare Corporation for instructions on how to manage the affected devices. The source text does not specify a particular action for consumers, as these are medical devices typically used in clinical settings.
The recalled product
- Product
- Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 14,601
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI 05413765852428
- all serial numbers
Distribution
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