24
Mar
2009

Cl l Baxter Colleague Infustion Pumps

,
0

Company: Baxter Healthcare Corp
Date of Enforcement Report 3/11/2009
Class:l

PRODUCT
Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps
Model numbers: Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163
These products were manufactured and distributed from February, 1997 through December, 2008.

REASON
The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death.

RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, Illinois

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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