FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151and 2M8151K (United Kingdom); Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display screen
- Recall number
- Z-0879-04
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151and 2M8151K (United Kingdom); Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display screen
- Status
- Terminated
- Initiated
- 2004-04-13
- Posted
- 2004-07-20
- Terminated
- 2011-02-02
- Reason
- Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.
- Root cause
- Nonconforming Material/Component
- Action
- Baxter sent urgent device correction letters dated 4/13/04 to the direct accounts to the attention of the Director of Biomedical Engineering on the same date. The letters informed the accounts of the ink deterioration of the letters, numbers and symbols on the Colleague Volumetric Infusion Pump programming and pump channel keypads, and informed them that over time such ink deterioration may impact legibility of the keys. The letters provided a listing of model numbers and serial numbers of pumps at their facility which may have potentially affected keypads. The accounts were given a sample of the overlay to be applied over the programming keypad and installation instructions as an interim fix while replacement keypads are obtained and installed as the pumps are processed through their depot repair centers. 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 overlays needed. Any questions were directed to Baxter at 1-800-843-7867. On 6/9/05, Baxter sent Urgent Device Correction letters to the accounts, to the attention of the Director of Biomedical Engineering, advising them that the replacement pump programming and pump channel keypads were now available.
- 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
- product code 2M8151- serial numbers 12040343CS and above; product code 2M8151K - serial numbers 13010001CK and above
- 510(k) numbers
- ["K953098","K010566"]
- 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