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

• Date Initiated by Firm: November 14, 2005
• Date Posted: January 28, 2006
• Recall Status: Terminated on June 19, 2007
• Recall Number: Z-0412-06
• Recall Event ID: 34020
• 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: All serial numbers of all product codes
• 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: Failures within the PCA profile as well as incidents resulting in interruptions of therapy in various profiles.
• FDA Determined Cause: Other
• Action: Baxter sent recall letters dated 11/14/05 to all of their 6060 pump customers on the same date via DHL overnight delivery. The accounts were informed of the reports of failures within the PCA profile and interruptions of therapy in various profiles. Due to the obsolescence of certain critical components, Baxter is conducting a controlled removal of all 6060 pumps from the market. Baxter will coordinate with customers individually to ensure a smooth transition to a substitute device. Baxter provided interim instructions to discontinue use of the PCA profile to avoid over infusion or non-delivery conditions, and to discontinue the use of the pump for therapies where interruption of the infusion could cause immediate patient harm. Baxter representatives telephoned each account within 48 hours of the letter, and visited them within a week to help the customers transition to other infusion pumps. A press release issued on 11/15/05. Baxter sent a follow-up recall letter to the accounts on 6/20/06, informing them that service repairs for the 6060 Infusion Pump will cease after 12/31/06, and compensation requests cannot be processed for pumps received after 12/31/06. Production of sets for the 6060 will cease on 10/1/06, and will not be available after 12/31/06. The accounts were requested to complete and fax back to Baxter the enclosed reply form, indicating the current inventory of 6060 pumps remaining at the facility.
• Quantity in Commerce: 34,000 pumps
• Distribution: Nationwide and internationally to Belgium, Germany, Finland, France, the United Kingdom, Ireland, Sweden, Norway, Canada, Japan, New Zealand and Australia.
• 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