Z-3008-2011

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation...

Name: Z-3008-2011 Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation...
Creator: Baxter Healthcare Corp.
Published: 2011-07-22
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2011-07-22 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Deerfield, IL; product code 2M8161 on 2011-07-22. The reason FDA records is "A review of Baxter service records indicates that the Baxter Colleague CX Infusion Pump has not met certain voltage specifications. This issue could potentially cause a delay in initiation of therapy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3008-2011
Status: Terminated
Initiated: 2011-07-22
Posted: 2011-08-11
Terminated: 2011-10-19
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Deerfield, IL; product code 2M8161
Product code: FRN Pump, Infusion
Reason for recall: A review of Baxter service records indicates that the Baxter Colleague CX Infusion Pump has not met certain voltage specifications. This issue could potentially cause a delay in initiation of therapy.
FDA root cause: Other
Action: The firm, Baxter, called by telephone on July 22, 2011, and sent a follow-up "Urgent Product Recall" letter dated July 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and take the affected pump out of service; call Baxter Global Technical Services at 1-800-THE-PUMP (1-800-843-7867), Option 1, between the hours of 6:00 AM and 7:00 PM Central Time, Monday through Friday, if arrangements have not yet been made to return the pump, and promptly complete and return the CUSTOMER REPLY FORM via fax to 847-270-5457, or scan and email to [email protected]. If you have any questions regarding this communication, please call the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time.
Quantity in commerce: 1 pump
Distribution: Nationwide distribution: Missouri only.
Product codes and lots: Product Code: 2M8161, Serial Number 12091459CC

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)