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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter SIGMA Spectrum Infusion Pump

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 Class 2 Device Recall Baxter SIGMA Spectrum Infusion Pumpsee related information
Date Initiated by FirmNovember 19, 2024
Date PostedDecember 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0776-2025
Recall Event ID 95848
510(K)NumberK230022 
Product Classification Pump, infusion - Product Code FRN
ProductBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Code Information GTIN 00085412498683; Serial Number: 2153638
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		Devices were identified as released after repair without full testing being performed, which includes flow testing.
FDA Determined
Cause 2		Process control
ActionCustomers were contacted via telephone beginning 11/19/24. Baxter Healthcare is calling to notify you of a potential issue with the Spectrum infusion pump. One of your devices has been identified as released after repair without full testing being performed, which includes flow testing. Baxter is requesting the return of the impacted infusion pump to perform all tests required and confirm that the infusion pump performs as expected. As part of this process, we need to make you aware of the potential hazard associated with flow related issues. Flow issues may cause excessive therapy, free-flow condition, insufficient therapy or interruption of therapy. These may lead to serious adverse health consequences, including permanent injury and death. Send signed form to Global CORP Service Quality Field Actions Global_CORP_Service_Quality_Field_Actions@baxter.com
Quantity in Commerce1 unit
DistributionUS Nationwide distribution in the states of AL, IN.
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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