Z-1022-05

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

Name: Z-1022-05 Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems...
Creator: Baxter Healthcare Corp.
Published: 2005-03-15
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-03-15 / Terminated / root cause: design

FDA source

Baxter Healthcare Corp. began a recall of Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, Deerfield, IL 60015 U.S.A., Made in Singapore... on 2005-03-15. The reason FDA records is "The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11". 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-1022-05
Status: Terminated
Initiated: 2005-03-15
Posted: 2005-07-21
Terminated: 2011-06-01
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R
Product code: FRN Pump, Infusion
Reason for recall: The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11.
Root cause tag: design
FDA root cause: Device Design
Action: Baxter sent the 3/15/05 Urgent Device Correction letter to all Colleague Infusion Pump customers to alert them of actions they can take in the short-term to address specific user actions and several error codes in the event of an occurrence, which could lead to serious adverse health consequences if a patient is receiving life-sustaining medication at the time of the pump failure. Users were urged to verify that the pump is infusing after pressing the Start key. If the hospital uses the external monitoring capabilities of the pump for a nurse call or remote pump monitoring, they were requested to ensure that the external computer or monitoring system does not send data to the pump, and that the pump is powered off when connecting and disconnecting the cable to the DB9 port to avoid a 16:336 failure code. If a 16:336 failure occurs the user is advised to power the pump off and back on again. The users were advised to have a contigency plan to mitigate any disruptions of infusions of life sustaining drugs if failure codes beginning with 402, 403, 533, 535 and 599 occur, and to take the pump out of service for inspection by authorized service personnel. The users were also advised to avoid getting fluid on the tubing set or in the pump channel to lessen the occurence of the 810:04 and 810:11 failure codes. If those code failures occur, the pump should be taken out of service for inspection by authorized service personnel. The users were informed that software upgrades are being developed to correct the inadvertent power off problem and to mitigate failure code 16:336 occurrences. 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: all serial numbers

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)