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Sigma spectrum infusion pump with master drug library (v8 platform)

Official notice

4 Jan 2022

Last checked

4 Jan 2022

Medium riskHealth Canada

An official Health Canada notice concerns Sigma spectrum infusion pump with master drug library (v8 platform). Baxter is communicating important safety information for Spectrum V8 and Spectrum IQ Infusion Pumps related to potential 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. Recall start date: December 29, 2021. Published 2022-01-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63793

Official notice

2022-01-04

The hazard

Baxter is communicating important safety information for Spectrum V8 and Spectrum IQ Infusion Pumps related to potential 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. Recall start date: December 29, 2021.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63793

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Affected products

Product 1

Affected Products - Sigma Spectrum Infusion Pump With Master Drug Library (V8 Platform), Lot or serial number - All lots., Model or catalog number - 35700BAX2

Risk / hazard

Baxter is communicating important safety information for Spectrum V8 and Spectrum IQ Infusion Pumps related to potential 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. Recall start date: December 29, 2021.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Baxter Healthcare, Sigma Spectrum Infusion Pump With Master Drug Library.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63793

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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