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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Spectrum

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  Class 2 Device Recall Baxter Spectrum see related information
Date Initiated by Firm April 09, 2024
Date Posted May 13, 2024
Recall Status1 Open3, Classified
Recall Number Z-1810-2024
Recall Event ID 94451
510(K)Number K230041  
Product Classification Pump, infusion - Product Code FRN
Product Spectrum IQ Infusion pump, Product Code 357009
Code Information UDI/DI 00085412610900, Serial Numbers: 3770692, 3770755, 3770781, 3770816, 3770932, 3771122, 3771364, 3771374, 3771419
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 There is a potential for cracks on the mount of the front panel of the device.
FDA Determined
Cause 2		 Under Investigation by firm
Action Baxter notified its consignees of the issue and requested an on-site inspection of the affected units on 04/09/2024 via telephone.
Quantity in Commerce 9 units
Distribution US Nationwide distribution in the states of Ohio, Wisconsin.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FRN and Original Applicant = Baxter Healthcare Corporation
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