Z-1059-05

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

Name: Z-1059-05 Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery...
Creator: Baxter Healthcare Corp.
Published: 2005-07-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-07-20 / 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 2005-07-20. The reason FDA records is "A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes". 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-1059-05
Status: Terminated
Initiated: 2005-07-20
Posted: 2005-08-10
Terminated: 2011-06-01
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, 2M8161, 2M8161R
Product code: FRN Pump, Infusion
Reason for recall: A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter sent the 7/20/05 Urgent Product Recall letter to all Colleague Infusion Pump customers, to the attention of the Director of Nursing and the Biomedical Engineer, via overnight delivery to alert them of a patient death which may have been associated with an electronic failure resulting from a design issue with the pump, and listed failure codes 402, 403, 532, 533, 534, 535, 702, 703, 704, 720, 804:22, 804:24, 804:29, 804:34, 804:52, 804:54, 804:58 and 12:303:xxx:0006 that may be related to the electronic failure. The users were advised to have a contingency plan to mitigate any disruptions of infusions of life sustaining drugs if the listed failure codes occur, and to take the pump out of service. They were also requested to review the event history of their pumps and take any pump with a previous history of the listed failures out of service. The accounts were also advised that all pumps processed through Baxter's service operations will be checked for the listed failure codes, and if a pump is found to have any of the codes in its event history, it will not be returned until a corrective action has been implemented. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867.
Quantity in commerce: 152,260 pumps
Distribution: Nationwide including Puerto Rico, and internationally to Australia, the Bahamas, Bahrain, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Arabia, South Africa, Taiwan, Turkey, the United Arab Emirates and teh United Kingdom.
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)