FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.
- Recall number
- Z-0598-2012
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.
- Status
- Terminated
- Initiated
- 2009-05-08
- Posted
- 2012-01-11
- Terminated
- 2012-01-03
- Reason
- There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.
- Root cause
- Process control
- Action
- Baxter sent a service technician to the consignee location on 05/08/2009 to perform the battery check and discharge test. The pump was found to be within specification.
- Quantity
- one pump
- Distribution
- Puerto Rico
- Lot, serial or model codes
- Product Code: 2M8161, Serial Number 12050019CC
- 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