Z-0483-2007

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

Name: Z-0483-2007 Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery...
Creator: Baxter Healthcare Corp.
Published: 2006-12-06
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2006-12-06 / Terminated

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 2006-12-06. The reason FDA records is "Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0483-2007
Status: Terminated
Initiated: 2006-12-06
Posted: 2007-01-11
Terminated: 2011-06-30
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, 2M8151R, 2M8161, 2M8161R
Product code: FRN Pump, Infusion
Reason for recall: Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user.
FDA root cause: Other
Action: Baxter sent the 12/6/06 Safety Alert letter to all Colleague Infusion Pump customers, to the attention of the Director of Radiation Oncology with copies to the Medical Physicist and Vice President of Nursing, via first class mail to advise them that the Colleague pump is not recommended for use in Linear Accelerator radiation therapy suites. The letters informed the users that there is a potential for a corruption of the memory chip to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user. The letter listed the error codes that may occur if the pump has been exposed to this type of radiation: 18:200, 18:416, 36:416, 19:113, 41:113, 314:432 and 302:435:XXXX:0006. If the pump displays any of the codes, the user was requested to submit the pump to their service facility. Failure code 199 may also occur and requires reconfiguration of the pump settings by the user's biomedical services organization. Any questions were directed to Baxter Global Technical Services at 1-800-843-7867, prompt 2.
Quantity in commerce: 267,317 pumps
Distribution: Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Honduras, Ireland, Israel, Italy, Jamaica, Korea, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, 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 serial numbers used in or near linear accelerator suites

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)