Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
Reported: March 21, 2018 Initiated: October 6, 2017 #Z-0971-2018
Product Description
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.
Reason for Recall
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 173,375
- Distribution
- Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.
- Location
- Medina, NY
Frequently Asked Questions
What product was recalled? ▼
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.. Recalled by Baxter Healthcare Corporation. Units affected: 173,375.
Why was this product recalled? ▼
Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 21, 2018. Severity: Moderate. Recall number: Z-0971-2018.
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