FDA recall Z-0971-2018

Baxter Healthcare Corporation · Class II · device

Product

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.

Distribution

Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.

Key facts

Status
Terminated
Initiation date
2017-10-06
Report date
2018-03-21
Termination date
2019-04-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Medina, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0971-2018