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U.S. Department of Health and Human Services

Class 1 Device Recall Baxter Novum IQ

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 Class 1 Device Recall Baxter Novum IQsee related information
Date Initiated by FirmApril 24, 2025
Date PostedMay 20, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1767-2025
Recall Event ID 96721
510(K)NumberK211122 
Product Classification Pump, infusion - Product Code FRN
ProductBaxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
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
800-422-9837
Manufacturer Reason
for Recall		There is a the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
FDA Determined
Cause 2		Device Design
ActionBaxter issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 04/24/2025 via USPS First Class Mail. The notice explained the issue, hazard, and requested the following: Actions to be Taken by Customers 1. For flow rates greater than 50 mL/hour, do not exceed a programmed standby time of 2 hours and 30 minutes. Monitor patients frequently to ensure that the appropriate infusion is being delivered. 2. Please remove the set upon powering off the device. 3. Post the enclosed informational poster with Novum IQ LVPs in your facility. 4. Acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 5. Please forward a copy of this communication to the Chief Medical Officer, Medical Director, Director of Nursing, Director of Pharmacy, Facility Risk Manager, Director of Purchasing/Central Supply, and any other departments within your institution who use the affected product. For general questions regarding this communication, or if you experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867 (select option 2, then option 2 again) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
Quantity in Commerce34,524 units
DistributionUS and Canada
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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