FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Deerfield, IL; product code 2M8161
- Recall number
- Z-3008-2011
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Deerfield, IL; product code 2M8161
- Status
- Terminated
- Initiated
- 2011-07-22
- Posted
- 2011-08-11
- Terminated
- 2011-10-19
- Reason
- A review of Baxter service records indicates that the Baxter Colleague CX Infusion Pump has not met certain voltage specifications. This issue could potentially cause a delay in initiation of therapy.
- Root cause
- Other
- Action
- The firm, Baxter, called by telephone on July 22, 2011, and sent a follow-up "Urgent Product Recall" letter dated July 25, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and take the affected pump out of service; call Baxter Global Technical Services at 1-800-THE-PUMP (1-800-843-7867), Option 1, between the hours of 6:00 AM and 7:00 PM Central Time, Monday through Friday, if arrangements have not yet been made to return the pump, and promptly complete and return the CUSTOMER REPLY FORM via fax to 847-270-5457, or scan and email to fca@baxter.com. If you have any questions regarding this communication, please call the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time.
- Quantity
- 1 pump
- Distribution
- Nationwide distribution: Missouri only.
- Lot, serial or model codes
- Product Code: 2M8161, Serial Number 12091459CC
- 510(k) numbers
- ["K063696"]
- 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