Class 2 Device Recall System 1000, Arena, 1550, BM11, BM25, Meridian

• Date Initiated by Firm: December 14, 2004
• Date Posted: December 24, 2004
• Recall Status: Terminated on February 26, 2008
• Recall Number: Z-0367-05
• Recall Event ID: 30507
• 510(K)Number: K970446 K030099 K872364 K894838 K911315A
• Product Classification: System, Dialysate Delivery, Sealed - Product Code FII
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Baxter Healthcare Renal Div; 1620 Waukegan Rd Bldg R; Mc Gaw Park IL 60085-6730
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: 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.
• FDA Determined 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.
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FII and Original Applicant = ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL; 510(K)s with Product Code = FII and Original Applicant = BAXTER HEALTHCARE CORP.; 510(K)s with Product Code = FII and Original Applicant = TRAVENOL LABORATORIES, S.A.