Z-1037-2009

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

Name: Z-1037-2009 Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery...
Creator: Baxter Healthcare Corp.
Published: 2009-01-23
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2009-01-23 / 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 2009-01-23. The reason FDA records is "Baxter has identified failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps". 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-1037-2009
Status: Terminated
Initiated: 2009-01-23
Posted: 2009-03-02
Terminated: 2011-10-04
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, 2M8161, 2M9161, DNM8151, DNM9161, BRM8151, BRM8151T, BRM8151RT, PNM8151, PNM8151T, PNM8151RT, CNM8151, FKM8151, GNM8151, HNM8151, TRM8151 and WNM8151. Electronic infusion pumps are indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
Product code: FRN Pump, Infusion
Reason for recall: Baxter has identified failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter Healthcare Corporation sent an "Urgent Device Correction" letter dated January 23, 2009 to all Colleague Infusion Pump customers, to the attention of the Vice President of Nursing with copies to the Chief Operating Officer, Director of Biomedical Engineering and Director of Risk Management to advise them of failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages associated with the Colleague pumps. The letters listed the failure codes involved that lead to an interruption of therapy which could lead to serious injury and/or death; advised institutions to have contingency plans to verify that back-up pumps are available; and provided steps for addressing an interruption of therapy with any failure code. The letters also provided information about the hazards associated with improper cleaning of the pumps and instructions for addressing damaged battery messages. Customers were instructed to complete the attached Customer Reply Form acknowledging receipt of the letter and fax it to 888-569-1585. Direct questions to your local Baxter Representative or to Baxter Global Technical Services by calling 1-800-843-7867, Prompt 2, between 7AM and 5 PM Central Standard Time (CST).
Quantity in commerce: 221,097 pumps
Distribution: Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Honduras, India, Ireland, Israel, Italy, Jamaica, Korea, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, United Kingdom and Venezuela.
Product codes and lots: All product numbers and all serial numbers.

Product code FRN

K063696Class IIColleague Volumetric Infusion Pump Model# 2M8151,8153,8161,8163,9161,9163Baxterhealthcare, Inc. / cleared 2007-02-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)