Jul

2005

Class I Baxter Healthcare Corporation

Company: Baxter Healthcare Corporation,
Date of Enforcement Report: 7/27/05
Class: I

PRODUCT
a) Baxter Colleague Single Channel Volumetric
Infusion Pumps, product codes: 2M8151,
2M8151R, 2M8161, 2M8161R, Recall # Z-1022-05;
b) Baxter Colleague triple Channel Volumetric
Infusion Pumps, product codes: 2M8153,
2M8153R, 2M8163, 2M8163R, Recall # Z-1023-05

REASON
The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11.

CODE
All serial numbers

RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Deerfield, IL, by letter on March 15, 2005.
Manufacturer: Baxter Healthcare Corporation, Singapore, Singapore. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
253,185 pumps

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

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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Class I Baxter Healthcare Corporation

Amy Sellers

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