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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 FirmNovember 23, 2020
Create DateDecember 23, 2020
Recall Status1 Open3, Classified
Recall NumberZ-0714-2021
Recall Event ID 86758
510(K)NumberK133801 
Product Classification Pump, infusion - Product Code FRN
ProductBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
Code Information Product Code 35700BAX2, GTIN 00085412498683
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
Manufacturer Reason
for Recall		There is a potential software error during programming.
FDA Determined
Cause 2		Under Investigation by firm
ActionA Medical Device Correction communication will be sent to all affected customers via U.S.P.S., first class mail. All pumps will be updated with new software which will prevent the malfunction from occurring. The software upgrade will be implemented upon next service or a local Baxter service representative will contact the facility to determine the correction plan and schedule the software update.
Quantity in Commerce140,006 devices
DistributionWorldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
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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