FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.
- Recall number
- Z-2796-2011
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2 M8153 and 2M8163. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.
- Status
- Terminated
- Initiated
- 2011-05-04
- Posted
- 2011-07-13
- Terminated
- 2017-01-10
- Reason
- The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.
- Root cause
- Employee error
- Action
- Baxter telephoned all seven affected customers beginning May 4, 2011, informing them that that a post repair test was not performed correctly on their Colleague pumps during the last service. As a result, the device Air Sensor may not function as designed and could lead to undetected air in the IV line. Baxter wants to ensure that the devices are properly tested, safe and effective. Baxter requested that they locate the pumps and remove them from use as soon as possible. Baxter will coordinate with the affected customers, the return of the device for the necessary testing to be completed at their facility and return of the device back to the customer at no cost. Please call ( 800 ) 437-5176 for a complaint that includes any indication of the failure of the product to meet a customer's expectations for quality or to meet performance specifications.
- Quantity
- 12 pumps
- Distribution
- Nationwide Distribution including the states of NY, Oh, KY,SC, PA, FL and Puerto Rico.
- Lot, serial or model codes
- Product Code 2 M8153, serial numbers 9070872CT and 12120279CT; Product Code 2M8163, serial numbers 14082199TC, 14090543TC, 13120195TC, 13120172TC, 13100660TC, 15041195TC, 11120467TC, 14082067TC, 12010398TC and 12010355TC
- 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