FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and previously marketed by Sabratek under product code 606194, Baxter Healthcare Corporation, Deerfield, IL 60015
- Recall number
- Z-1569-05
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Lock Box for 100 mL or 250 mL Bag Set, for use with 6060 Pump Family; Baxter product code 2L9354 and previously marketed by Sabratek under product code 606194, Baxter Healthcare Corporation, Deerfield, IL 60015
- Status
- Terminated
- Initiated
- 2004-09-01
- Posted
- 2005-04-22
- Terminated
- 2006-07-21
- Reason
- The pump may free-flow if the door to the 6060 pump is not closed prior to loading the pump in to the lock box. The pump will alarm 'Door Open', but if the pump is turned off to silence the alarm while remaining in the lock box, the fluid will free-flow.
- Root cause
- Other
- Action
- Urgent Device Correction letters dated 9/1/04 were sent to all U.S. Baxter affected customers on the same date, to the attention of the Director of Nursing. The facilities were advised of the free-flow incident and as a result that Baxter wanted to heighten awareness of the proper clinical procedures for loading the sets into the infusion systems using these Lock Boxes with the 6060 Multi-Therapy Pump. Baxter''s investigation into the event confirmed that the 6060 pump door was left open after the lock box was attached to the pump. Baxter provided copie of the instructions for use of the lock box and pages from the 6060 pump operator''s manual which outline the proper procedure for loading the sets into the the pump and the pump into the lock box. The accounts were requested to complete and fax back to Baxter the enclosed response form, erifying receipt of the letter, confirming that the information has been provided to all users of the infusion system, and allowing Baxter to order and ship labels for the lock box and revised instructions for use to the facility. Any questions were directed to 1-800-843-78867.
- Quantity
- 640 units
- Distribution
- Nationwide and internationally to Australia, Belgium, Canada, France, Hong Kong, Portugal, Spain and the United Kingdom.
- Lot, serial or model codes
- all lot numbers/serial numbers of product codes 2L9354 and 606194
- 510(k) numbers
- ["K002679"]
- 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