Class 2 Device Recall Baxter 1550 Hemodialysis Machine

• Date Initiated by Firm: January 29, 2010
• Date Posted: April 12, 2010
• Recall Status: Terminated on February 03, 2011
• Recall Number: Z-1322-2010
• Recall Event ID: 54373
• 510(K)Number: K883111 K922757B
• Product Classification: System, dialysate delivery, single patient - Product Code FKP
• Product: Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.
• Code Information: All Baxter 1550 instruments and/or spare circuit boards that do not have software versions 3.0A or 4.1B
• 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: Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.
• FDA Determined Cause: Software change control
• Action: An "Urgent Device Correction" letter dated January 29, 2010 was sent to the direct accounts via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letter informed the accounts that subsequent to a prior device field correction in 2003-2004, some 1550 hemodialysis instruments may have replacement circuit boards with incorrect versions of software. The accounts were instructed to confirm the software version in their systems and replacement boards. Instructions for checking the software version were attached to the letter. A complementary software upgrade will be made available to the account if their 1550 instrument and/or spare circuit board inventory has a software version other than 3.0A or 4.1B. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and listing the serial numbers and software versions of those instruments that do nit have software 3.0A or 4.1B. Home patients were not notified directly, the information was sent to their Dialysis Center. The 1550 operator's manual was revised during the 2003 device field correction. The manual correctly warns the operator to discontinue treatment if the 1550 experiences a FL04, FL07, or FLOg fault code. To make arrangements for the software upgrade or questions regarding the communication were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3. For additional questions, contact the company Monday through Friday from 8:00 AM to 5:00 PM CST at (Toll Free): 800-422-9837.
• Quantity in Commerce: 443 boards
• Distribution: Worldwide Distribution -- United States - nationwide and Puerto Rico, Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Mexico, Panama, Philippines, Romania, Turkey and Venezuela.
• 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 = FKP and Original Applicant = BAXTER HEALTHCARE CORP.