FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product code 2M8161
- Recall number
- Z-1224-2007
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product code 2M8161
- Status
- Terminated
- Initiated
- 2007-08-15
- Posted
- 2007-09-19
- Terminated
- 2008-02-21
- Reason
- Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.
- Root cause
- Other
- Action
- The affected hospitals were sent an Urgent Colleague Deployment Correction letter dated 8/15/07 via overnight mail. The hospitals were informed that some of the Colleague pumps at their facility may not have been completely upgraded to include all the necessary components required as part of Baxter's Corrective Action Plan (CAP). The hospitals were provided a list of affected pump serial numbers and were requested to remove the pumps from clinical use and notify all end users of the action. The accounts were requested to complete the enclosed customer reply form, acknowledging the receipt and understanding of the letter and fax it back to Baxter at 1-847-270-5457. The hospitals were also requested to report any malfunction or adverse event related to the Colleague Infusion Pumps to Baxter Corporate Product Surveillance at 1-800-437-5176.
- Quantity
- 42 pumps
- Distribution
- Florida and California
- Lot, serial or model codes
- product code 2M8161, serial numbers 14051565CC, 15034273CC, 15034492CC, 15040255CC, 15041116CC, 15041169CC, 15041170CC, 15041172CC, 15041181CC, 15041194CC, 15041199CC, 15041206CC, 15041212CC, 15041218CC, 15041241CC, 15041288CC, 15041290CC, 15041317CC, 15050020CC, 15050034CC, 15050045CC, 15050061CC, 15050080CC, 15050117CC, 15050129CC, 15060087CC, 15060217CC, 15060253CC, 15060479CC, 15060489CC, 15060549CC, 15060557CC, 15060600CC, 15060738CC, 15060790CC, 15060827CC, 15060939CC, 15060940CC, 15060968CC, 15063211CC, 15075371CC, 15075103CC
- 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