FDA recall Z-0530-2022

Product

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.

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.

Key facts

Status

Ongoing

Initiation date

2021-12-29

Report date

2022-02-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0530-2022