Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling approximately 146,502 SIGMA Spectrum Infusion Pump units with Master Drug Library Version 8 (product code 35700BAX2) distributed worldwide, including throughout the United States, Puerto Rico, St. Thomas, Canada, and several Caribbean nations. The pumps may deliver reduced or no medication to patients in some cases, and in certain situations may fail to alert users through an alarm. This hazard can occur when an administration set is incorrectly set up or when an upstream occlusion alarm is not completely resolved on Spectrum V8 and Spectrum IQ infusion pumps.
The source document does not specify what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
Reason for recall: There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps. Distribution: Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago. Quantity: 146,502 units Lot/code info: All serial numbers, GTIN 00085412498683.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.