FDA Medical Device Recalls (openFDA)
Baxter Healthcare Renal Div: System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
- Recall number
- Z-0347-06
- Recalling firm
- Baxter Healthcare Renal Div
- Product
- System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
- Status
- Terminated
- Initiated
- 2005-11-18
- Posted
- 2006-01-06
- Terminated
- 2008-03-04
- Reason
- Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air emboli condition.
- Root cause
- Other
- Action
- Baxter sent Urgent Device Correction letters dated 11/18/05 to all System 1000, TINA, Aurora and Arena Hemodilaysis Instrument customers via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that the potential exists for fluid or air to be passed through the venouus line clamp that could result in an air emboli condition. This condition can occur when the tubing is not centered on the clamp and extends beyond the edge of the clamp''s pinch zone. Baxter will make arrangements to upgrade the instruments with either a linear or rotary venous line clamp upgrade as soons as they become available within the next three months. The letters included copies of a diagram showing the correct and incorrect placement of the tubing in the clamp, and a Technical Service Bulletin that provided an adjustment procedure to perform an interim correction to the linear line clamp configuration prior to the upgrade. Any questions regarding the execution of this procedure were directed to Baxter Global Technical Services at 1-800-553-6898.
- Quantity
- 29,173 machines
- Distribution
- Nationwide and internationally to Canada, Korea, Hong Kong, Shanghai, Jamaica, Philippines, United Kingdom, Denmark, India, Belgium, Mexico, Italy, Austria, Sweden, Ecuador, Argentina, Brazil, Chile, Colombia, Peru, Turkey and Australia.
- Lot, serial or model codes
- product codes S1000L3, S1000L3P, S1000LC2, S1000L3T, S1000L3TD, S1000L3PR, ARENASP, ARENASPP, ARENASPX, ARENADPX; all serial numbers
- 510(k) numbers
- ["K013562","K030099","K910215"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3000210122
- Firm city
- Park
- 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