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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Baxter Healthcare Renal Div
Lot Codes / Batch Numbers
System 1000: serial numbers 1001S-1142S, 50001-52109
Products Sold
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
Baxter Healthcare Renal Div is recalling System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 a due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026