25
Jul
2007

Class l Baxter Healthcare Corp.

,
0

Company:Baxter Healthcare Corp
Date of Enforcement Report:7/25/2007
Class:l

PRODUCT
Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore, product codes 2M8153, 2M8163, 2M9163, Recall # Z-1091-2007

REASON
A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels simultaneously infusing fluids. In reported cases, the pump stopped infusing and both an audible and a visual alarm notification were activated.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on June 20-21, 2007 and by letters dated June 22, 2007.
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4,512 pumps

DISTRIBUTION
Nationwide and Internationally

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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