FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8153, 2M8153R, 2M8163, 2M8163R
- Recall number
- Z-1544-05
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8153, 2M8153R, 2M8163, 2M8163R
- Status
- Terminated
- Initiated
- 2005-02-25
- Posted
- 2005-09-23
- Terminated
- 2011-02-16
- Reason
- Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after teh Battery Depleted alarm occurs.
- Root cause
- Labeling design
- Action
- Baxter sent letters dated 02/25/05 to all Colleague infusion pump customers to provide them with important supplemental information to the letter dated 1/21/03 (Z-929-1), regarding sealed lead-acid batteries used in the Colleague family of infusion pumps, dealing with swollen batteries and excessive deep discharge. The 2/25/05 letter reiterated the battery service life, replacement and pump storage conditions which were listed in the 1/21/03 letter, and informed the users that current production pumps have an overcurrent protection circuit in the battery harness to help protect the batteries from overcurrent damage and swelling during charging, and advised them of the availability of the battery harness. The letters also provided information to prevent excessive discharge, and advised them that software updates will become available later in 2005. An Operator's Manual Addendum was also included with the 2/25/05 letter, replacing chapter 7 of the manual dealing with Maintenance and Service. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867.
- Quantity
- 53,686 pumps
- Distribution
- Nationwide including Puerto Rico, and internationally to Taiwan, Canada, Chile, Korea, Colombia, New Zealand, China, Hong Kong, Brazil, Turkey and Saudi Arabia.
- Lot, serial or model codes
- product codes 2M8153 and 2M8153R: all serial numbers below 13120001CT; product codes 2M8163 and 2M8163R: all serial numbers below 13110338TC
- 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