Z-0345-05

Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare...

Name: Z-0345-05 Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare...
Creator: Baxter Healthcare Corp.
Published: 2004-11-04
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2004-11-04 / Terminated / root cause: software

FDA source

Baxter Healthcare Corp. began a recall of Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in... on 2004-11-04. The reason FDA records is "A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0345-05
Status: Terminated
Initiated: 2004-11-04
Posted: 2004-12-22
Terminated: 2011-02-02
Recalling firm: Baxter Healthcare Corporation
Product: Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen
Product code: FRN Pump, Infusion
Reason for recall: A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.
Root cause tag: software
FDA root cause: Other
Action: Baxter sent Urgent Device Correction letters dated 11/4/04 to the direct accounts to the attention of the Director of Biomedical Engineering on the same date. The letters informed the accounts of the 12:303 failure and possible interruption of patient therapy when it occurs. They were informed that new software was available to address the failure alarm code with the infusion pumps, and that the software also included updates to the predefined label library and the addition of a text message 'Close regulating roller clamp' to the manual tube release pop-up message. The software is being installed on all single and triple channel Colleague infusion pumps as they are processed through Baxter''s depot repair centers for other repair actions or routine maintenance. An Operator''s Manual Addendum was included with the letter to reflect the changes to the label library and the manual tube release pop-up message. The accounts were requested to complete the attached reply form and return it via fax to Baxter. The completed form acknowledges receipt of the recall letter, verifies the model numbers and serial numbers of the pumps at the facility and indicates the number of revised software installation kits needed by self-service customers. Any questions were directed to Baxter at 1-800-843-7867.
Distribution: Nationwide and internationally to Australia, the Bahamas, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates and the United Kingdom.
Product codes and lots: all serial numbers

Product code FRN

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)