Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
This recall is currently active, issued November 23, 2020. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- November 23, 2020
- Recall Number
- Z-0712-2021
- Quantity
- 9,353 devices
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential software error during programming.
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Lot / Code Info
Product Code 35700ABB, GTIN 00085412091570
Root Cause
Under Investigation by firm
Action Taken
A 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.