Baxter SIGMA Spectrum Infusion Pump with Master Drug… recallZ-0775-2025 · Baxter Healthcare Corporation · initiated Nov 19, 2024
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
Devices were identified as released after repair without full testing being performed, which includes flow testing.
FDA root cause category: Process control
What the company is doing
Customers 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 [email protected]
Recall details
- Recall number
- Z-0775-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 19, 2024
- Posted by the FDA
- Dec 27, 2024
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 1 units
- Product code
- FRN
- FDA submissions
- K133801
- Distribution
- US Nationwide distribution in the states of AL, IN.
Product description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX
Code information (models, lots, serial numbers)
GTIN 00085412091570; Serial Number: 779515
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 95848).
- Z-0776-2025 · Open, ClassifiedBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
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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