Z-0598-2012

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps

Name: Z-0598-2012 Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps
Creator: Baxter Healthcare Corp.
Published: 2009-05-08
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2009-05-08 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161 on 2009-05-08. The reason FDA records is "There was no documentation to show the required tests were performed following the replacement of the battery and battery harness". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0598-2012
Status: Terminated
Initiated: 2009-05-08
Posted: 2012-01-11
Terminated: 2012-01-03
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.
Product code: FRN Pump, Infusion
Reason for recall: There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Baxter sent a service technician to the consignee location on 05/08/2009 to perform the battery check and discharge test. The pump was found to be within specification.
Quantity in commerce: one pump
Distribution: Puerto Rico
Product codes and lots: Product Code: 2M8161, Serial Number 12050019CC

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)