FDA Medical Device Recalls (openFDA)
Baxter Healthcare Renal Div: System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
- Recall number
- Z-0367-05
- Recalling firm
- Baxter Healthcare Renal Div
- Product
- System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
- Status
- Terminated
- Initiated
- 2004-12-14
- Posted
- 2004-12-24
- Terminated
- 2008-02-26
- Reason
- Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism.
- Root cause
- Other
- Action
- An Urgent Device Correction letter dated 12/14/04 was sent along with a reply form and addenda to operator''s manuals to all Baxter customers who have purchased hemodialysis hardware. The letter informed the accounts of reports of air bubbles observed in the tubing sets past the air detector without an alarm alerting the operator of potential air in the tubing. A review of the reports revealed misuse, including failure to follow generally observed hemodialysis practices. Baxter updated their Hemodialysis Operator''s Manuals and Training Guides to clarify instructions and add caution and warning statements to address the possibility of introducing air in the extracorporeal circuit and to clarify methods for clearing air from the circuit. The accounts were requested to review the attached addendum that applies to the instruments used in their facility against the pertinent sections of their Operator''s Manual. If their Operator''s Manual does not match the addendum, they were instructed to order a new manual using the enclosed response form. Any questions were directed to Baxter''s Global Technical Services at 1-800-553-6898.
- Quantity
- not on file
- Distribution
- This action covers Baxter''s complete line of hemodialysis hardware, which was distributed nationwide, including Puerto Rico, and internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Korea, Lebanon, Morocco, Malaysia, Netherlands, Oman, Panama, Peru, Philippines, Poland, Palestine, Romania, Russia, Saudia Arabia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and the United Kingdom.
- Lot, serial or model codes
- System 1000: serial numbers 1001S-1142S, 50001-52109, 01001-22223 Arena: serial numbers 300001-300640 1550: serial numbers 52599-67210 BM11: all serial numbers BM25: all serial numbers Meridian: serial numbers 200101-203156
- 510(k) numbers
- ["K030099","K872364","K894838","K970446"]
- PMA numbers
- not on file
- Product code
- FII
- 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