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U.S. Department of Health and Human Services

Class 2 Device Recall Spectrum IQ

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 Class 2 Device Recall Spectrum IQsee related information
Date Initiated by FirmJuly 14, 2025
Date PostedAugust 22, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2415-2025
Recall Event ID 97335
510(K)NumberK230041 
Product Classification Pump, infusion - Product Code FRN
ProductSpectrum IQ Infusion Pump, Product Code 3570009
Code Information UDI-DI: 00085412610900; Serial Numbers: 3815255 3815261 3815265 3815266 3815267 3815271
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		Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCustomers were contacted via telephone beginning 7/14/25. The included information about the product, the issue and the action to be taken by the customers. Baxter Healthcare is requesting the return of the impacted product to perform all tests required and confirm that the product perform as expected. If you have any questions, phone (Toll Free): 800-422-9837 or 847-948-4770; hours of operation: Monday through Friday from 8:00 am to 5:00 pm CST
Quantity in Commerce6 units
DistributionUS distribution to states of: AZ, FL
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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