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U.S. Department of Health and Human Services

Class 1 Device Recall Baxter Novum IQ Syringe Infusion System

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 Class 1 Device Recall Baxter Novum IQ Syringe Infusion Systemsee related information
Date Initiated by FirmOctober 13, 2023
Date PostedNovember 09, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0151-2024
Recall Event ID 93191
510(K)NumberK211125 
Product Classification Pump, infusion - Product Code FRN
ProductNovum IQ Syringe infusion system, Product Code 40800BAXUS
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-8937
Manufacturer Reason
for Recall		Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.
FDA Determined
Cause 2		Under Investigation by firm
ActionBaxter issued an "Urgent Medical Device Correction" notice on 10/13/2023 via USPS first-class mail. The notice explained the issue, hazard involved, and provided mitigation procedures in accordance with the Operator's Manual until a software upgrade becomes available. For additional questions or experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867, Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
Quantity in Commerce2023 units
DistributionUS Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, PA, TX, UT, VA, VT, WA, WI AND WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
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