Baxter SIGMA Spectrum Infusion Pump with Master Drug… recallZ-0712-2021 · Baxter Healthcare Corporation · initiated Nov 23, 2020
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is a potential software error during programming.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0712-2021
- Status
- Open, Classified
- Initiated by the company
- Nov 23, 2020
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 9,353 devices
- Product code
- FRN
- FDA submissions
- K042121
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Barbados, Jamaica, Bermuda, Guyana, Bahamas, and Trinidad and Tobago.
Product description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids.
Code information (models, lots, serial numbers)
Product Code 35700ABB, GTIN 00085412091570
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SPECTRUM WITH MDL 35700BAXBaxter International Inc. · Pump, infusion6 recalls1 death2,077 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 86758).
- Z-0714-2021 · Open, ClassifiedBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the controlled administration of fluids.
- Z-0715-2021 · Open, ClassifiedBaxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled administration of fluids.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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