FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155; Baxter Healthcare Corporation, Deerfield, IL
- Recall number
- Z-0778-05
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155; Baxter Healthcare Corporation, Deerfield, IL
- Status
- Terminated
- Initiated
- 2005-03-02
- Posted
- 2005-04-27
- Terminated
- 2006-05-23
- Reason
- The Configuration Tranfer Cable for the Colleague Infusion Pumps has incorrect thumb screws on it., not allowing firm connections of the cable to the pump to transfer data to the biomedical engineer's diagnostic device.
- Root cause
- Other
- Action
- Recall letters dated 3/2/05 were sent to all customers receiving Configuration Transfer Cables between June and November 2004. The letters were sent to the attention of the Biomedical Engineer, and informed them that the thumbscrews were not manufactured according to Baxter''s specifications and were too narrow to secure the cable to the pump. The accounts were requested to return their Configuration Transfer Cables for replacement.
- Quantity
- 404 cables
- Distribution
- Nationwide, and internationally to Brazil, Canada, Chile, China, Colombia, Hong Kong, Korea, New Zealand, Japan, Taiwan, Saudi Arabia and Turkey.
- Lot, serial or model codes
- Product code 2M8155, batch #50604
- 510(k) numbers
- not on file
- 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