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U.S. Department of Health and Human Services

Class 2 Device Recall SIGMA Spectrum Infusion Pump

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 Class 2 Device Recall SIGMA Spectrum Infusion Pumpsee related information
Date Initiated by FirmJune 14, 2024
Date PostedAugust 07, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2530-2024
Recall Event ID 94959
510(K)NumberK230022 
Product Classification Pump, infusion - Product Code FRN
ProductBaxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Code Information Product Code: 35700BAX2. Serial Number: 2158913.
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		Improperly performed testing prior to release
FDA Determined
Cause 2		Under Investigation by firm
ActionThe impacted customer was contacted via phone call on 6/14/2024. Baxter has asked the customer to locate the affected pump at their facility and return the device to Baxter to be serviced.
Quantity in Commerce1 unit
DistributionUS Nationwide distribution in the state of Florida.
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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