FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, BRM8153(Brazilian Portugese), DNM8153(French), HNM8153(German), PNM8153(Spanish), CNM8153(Swedish), GNM8153(Danish), TRM8153(Turkish), WNM8153(Dutch) ,2M8163, 2M8163R
- Recall number
- Z-0445-06
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, BRM8153(Brazilian Portugese), DNM8153(French), HNM8153(German), PNM8153(Spanish), CNM8153(Swedish), GNM8153(Danish), TRM8153(Turkish), WNM8153(Dutch) ,2M8163, 2M8163R
- Status
- Terminated
- Initiated
- 2005-12-13
- Posted
- 2006-01-31
- Terminated
- 2011-11-30
- Reason
- Interruption of therapy due to battery undercharging, the generation of air-in-line alarms due to IV administration set tugging, and gearbox wear; and underinfusion due to misalignment of the pump head components.
- Root cause
- Device Design
- Action
- Baxter sent the 12/13/05 Urgent Device Correction letter to all Colleague Infusion Pump customers, to the attention of the Director of Nursing and the Biomedical Engineer, via first class mail to alert them to additional problems with the pump that may interrupt therapy. These issues include battery undercharging, generation of false air detected alarms due to IV administration set tugging, gearbox wear, underinfusion and non-detection of upstream occlusions. The letters included mitigating instructions to reduce the occurrence of these potential problems, and included a copy of the Battery Usage Guide, Infusion Management Guide, and the March 17, 2005 Buretrol Set Urgent Device Correction letter to be provided to all users of the Colleague pump. Baxter informed the accounts that they would be notified when the new release of the Colleague Volumetric Infusion Pump Operator''s Manual is available. Any questions were directed to Baxter''s Medication Delivery Services at 1-800-843-7867.
- Quantity
- 53,686 pumps
- Distribution
- Worldwide distribution: USA, Puerto Rico, United Kingdom, Canada, Brazil, Hong Kong, Taiwan, Turkey, Kuwait, South Africa, Chile, Saudi Arabia, Korea, Mexico, Colombia, New Zealand, the Bahamas, Belgium, El Salvador, Guatemala, Honduras, Israel, Lebanon, Panama, the Philippines and the United Arab Emirates.
- Lot, serial or model codes
- all serial numbers
- 510(k) numbers
- ["K041191"]
- 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