Z-1543-05

Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems...

Name: Z-1543-05 Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems...
Creator: Baxter Healthcare Corp.
Published: 2005-02-25
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-02-25 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corp. began a recall of Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8151, 2M8151R, 2M8161, 2M8161R on 2005-02-25. The reason FDA records is "Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1543-05
Status: Terminated
Initiated: 2005-02-25
Posted: 2005-09-23
Terminated: 2011-02-16
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8151, 2M8151R, 2M8161, 2M8161R
Product code: FRN Pump, Infusion
Reason for recall: Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after teh Battery Depleted alarm occurs.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Baxter sent letters dated 02/25/05 to all Colleague infusion pump customers to provide them with important supplemental information to the letter dated 1/21/03 (Z-929-1), regarding sealed lead-acid batteries used in the Colleague family of infusion pumps, dealing with swollen batteries and excessive deep discharge. The 2/25/05 letter reiterated the battery service life, replacement and pump storage conditions which were listed in the 1/21/03 letter, and informed the users that current production pumps have an overcurrent protection circuit in the battery harness to help protect the batteries from overcurrent damage and swelling during charging, and advised them of the availability of the battery harness. The letters also provided information to prevent excessive discharge, and advised them that software updates will become available later in 2005. An Operator's Manual Addendum was also included with the 2/25/05 letter, replacing chapter 7 of the manual dealing with Maintenance and Service. 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 Taiwan, Canada, Chile, Korea, Colombia, New Zealand, China, Hong Kong, Brazil, Turkey and Saudi Arabia.
Product codes and lots: product codes 2M8151 and 2M8151R: all serial numbers below 13120001CS; product codes 2M8161 and 2M8161R: all serial numbers below 13110181CC

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)