FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen
- Recall number
- Z-0345-05
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen
- Status
- Terminated
- Initiated
- 2004-11-04
- Posted
- 2004-12-22
- Terminated
- 2011-02-02
- Reason
- A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.
- Root cause
- Other
- Action
- Baxter sent Urgent Device Correction letters dated 11/4/04 to the direct accounts to the attention of the Director of Biomedical Engineering on the same date. The letters informed the accounts of the 12:303 failure and possible interruption of patient therapy when it occurs. They were informed that new software was available to address the failure alarm code with the infusion pumps, and that the software also included updates to the predefined label library and the addition of a text message 'Close regulating roller clamp' to the manual tube release pop-up message. The software is being installed on all single and triple channel Colleague infusion pumps as they are processed through Baxter''s depot repair centers for other repair actions or routine maintenance. An Operator''s Manual Addendum was included with the letter to reflect the changes to the label library and the manual tube release pop-up message. The accounts were requested to complete the attached reply form and return it via fax to Baxter. The completed form acknowledges receipt of the recall letter, verifies the model numbers and serial numbers of the pumps at the facility and indicates the number of revised software installation kits needed by self-service customers. Any questions were directed to Baxter at 1-800-843-7867.
- Quantity
- not on file
- Distribution
- Nationwide and internationally to Australia, the Bahamas, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates and the United Kingdom.
- Lot, serial or model codes
- all serial numbers
- 510(k) numbers
- ["K003616","K002211"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28