Z-0444-06

Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery...

Name: Z-0444-06 Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery...
Creator: Baxter Healthcare Corp.
Published: 2005-12-13
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-12-13 / Terminated / root cause: design

FDA source

Baxter Healthcare Corp. began a recall of Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in... on 2005-12-13. The reason FDA records is "Interruption of therapy due to battery undercharging, the generation of air-in-line alarms due to IV administration set tugging, and gearbox wear; and underinfusion due to misalignment of the pump head components". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0444-06
Status: Terminated
Initiated: 2005-12-13
Posted: 2006-01-31
Terminated: 2011-11-30
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, BRM8151(Brazilian Portugese), DNM8151(French), HNM8151(German), PNM8151(Spanish), CNM8151(Swedish), GNM8151(Danish), TRM8151(Turkish), WNM8151(Dutch) , 2M8161, 2M8161R
Product code: FRN Pump, Infusion
Reason for recall: Interruption of therapy due to battery undercharging, the generation of air-in-line alarms due to IV administration set tugging, and gearbox wear; and underinfusion due to misalignment of the pump head components.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter sent the 12/13/05 Urgent Device Correction letter to all Colleague Infusion Pump customers, to the attention of the Director of Nursing and the Biomedical Engineer, via first class mail to alert them to additional problems with the pump that may interrupt therapy. These issues include battery undercharging, generation of false air detected alarms due to IV administration set tugging, gearbox wear, underinfusion and non-detection of upstream occlusions. The letters included mitigating instructions to reduce the occurrence of these potential problems, and included a copy of the Battery Usage Guide, Infusion Management Guide, and the March 17, 2005 Buretrol Set Urgent Device Correction letter to be provided to all users of the Colleague pump. Baxter informed the accounts that they would be notified when the new release of the Colleague Volumetric Infusion Pump Operator''s Manual is available. Any questions were directed to Baxter''s Medication Delivery Services at 1-800-843-7867.
Quantity in commerce: 152,260 pumps
Distribution: Worldwide distribution: USA, Puerto Rico, United Kingdom, Canada, Brazil, Hong Kong, Taiwan, Turkey, Kuwait, South Africa, Chile, Saudi Arabia, Korea, Mexico, Colombia, New Zealand, the Bahamas, Belgium, El Salvador, Guatemala, Honduras, Israel, Lebanon, Panama, the Philippines and the United Arab Emirates.
Product codes and lots: all serial numbers

Product code FRN

K041191Class IIColleague Volumetric Infusion PumpsBaxter Healthcare Corp / cleared 2004-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)