Class 2 Device Recall Baxter 6060 & Sabratek 6060 Homerun MultiTherapy Infusion Pump

• Date Initiated by Firm: November 07, 2005
• Date Posted: January 28, 2006
• Recall Status: Terminated on June 19, 2007
• Recall Number: Z-0411-06
• Recall Event ID: 33999
• 510(K)Number: K002679
• Product Classification: Pump, Infusion - Product Code FRN
• Product: Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore
• Code Information: product codes 2M9832, 2M9832P and 2M9832R; product codes 606000, 606000-40, 606000-40L, and 606000-40I; 2M9832: serial numbers 501001HR-501263HR, 502001HR-502156HR, 503001HR-503155HR, 505001HR-505210HR, 507001HR-507054HR, 502001HG-502060HG, 503001HG-503048HG, 505001HG-505276HG, 506001HG-506180HG, 501001HJ-501072HJ, 502001HJ-502072HJ, 503001HJ-503060HJ, 504001HJ-504060HJ, 505001HJ-505060HJ, 501001HW-501020HW, 502001HW-502024HW, 501001HF-501012HF, 502001HF-502024HF
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp.; Rt. 120 & Wilson Rd; Round Lake IL 60073
• For Additional Information Contact: Center for One Baxter ; 800-422-9837
• Manufacturer Reason for Recall: Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test.
• FDA Determined Cause: Other
• Action: Baxter sent Urgent Device Correction letters dated 11/7/05 to the user accounts, advising them of the potential for the circuit boards in the 6060 pump to fail due to a problem that occurred in the supplier's manufacturing process. The letter included a list of 6060 pump serial numbers sent to the user that may contain an affected circuit board. To mitigate safety risks to the patient, Baxter advised customers to immediately discontinue use of the pump for therapies where interruption of the infusion could cause immediate patient harm. In addition, the pump is not to be used if it fails the Power-On Self Test. The accounts were instructed to contact Baxter Medication Delivery Services at 1-800-843-7867 for information regarding the return process for the affected 6060 pumps for correction. Baxter sent follow-up letters dated 2/16/06 to the accounts, to the attention of the Director of Biomedical Engineering, informing them that Baxter has sufficient quantities of replacement circuit boards to begin the repairs. The accounts were requested to review the enclosed list of serial numbers for accuracy and telephone Baxter at 1-800-843-7867 to schedule the return of any 6060 Infusion Pump that requires replacement of the circuit board.
• Quantity in Commerce: 3,141 pumps
• Distribution: Nationwide, and internationally in France, Germany, Sweden and teh 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 = FRN