Class 2 Device Recall Medfusion Syringe Infusion Pump

• Date Initiated by Firm: December 18, 2008
• Date Posted: March 09, 2009
• Recall Status: Terminated on July 06, 2012
• Recall Number: Z-1019-2009
• Recall Event ID: 50711
• 510(K)Number: K040899
• Product Classification: Pump, infusion - Product Code FRN
• Product: Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V4.1.5. A small, lightweight and portable syringe infusion pump. ; ; ; The Medfusion 3500 syringe pump is indicated for use with the following delivery routes: Arterial, Epidural, Enteral, Intravenous, Spinal, Subcutaneous for delivering the following fluids: Intravenous solutions, drug Solutions, blood or blood products and enteral feedings.
• Code Information: Serial Numbers: M50515-M50649, M51602-M51637, M51647, M51648, M51664-M51671, M51762-M51931, M51933-M51935, M51940-M51951, M51954-M51958, M51960-M51964, M51966-M51970, M51972-M51976, M51978-M51982, M51984-M51994, M51996, M51997, M51999, M52000, M52002-M52006, M52008-M52012, M52014-M52018, M52020-M52024, M52026-M52030, M52032-M52051, M52053, M52055, M52056, M52059, M52060, M52062, M52063, M52065, M52066, M52067, M52069, M52071-M52073, M52075, M52093, M52112-M52121, M52124, M52125, M52130, M52131, M52203-M52209, M52211-M52218, M52313-M52342, M53923, M54234-M54330, M54332-M54335, M54857-M54944, M55007-M55086, M55092-M55227, M55697, M56236-M56242, M56464-M56483, M56687, M56688, M56690-M56701, M56703-M56707, M57358-M57421, M57466-M57961, M57966-M57986, M58538-M58657, M58831-M58860, M58940-M58949, M59177 and M59178. 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• Recalling Firm/ Manufacturer: Smiths Medical MD, Inc.; 1265 Grey Fox Rd; Saint Paul MN 55112-6929
• For Additional Information Contact: 651-628-7280
• Manufacturer Reason for Recall: Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 ("Pump") have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may render the Pump inoperable or the Pump may not respond to certain keypad button presses.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Consignees were initially notified of the recall via a telephone conversation beginning December 18, 2008 and continued through January 2009. After the initial telephone contact, an "Urgent Medical Device Recall" letter dated December 22, 2008 was sent via electronic mail. The letter was addressed to "Affiliates, Distributors, Clinicians, and other Customers". The letter gave a Description of the Problem and Advise on Action to be Taken by the User. Direct questions to Smiths Medical Customer Service department at 1-800-426-2448 (option 1, then option 3). A Smiths Medical Customer Service Representative will have contacted customers. These pumps will be fitted with new keypads with gold connectors. A second Smiths Medical "Urgent Medical Device Recall Additional Affected Units"recall letter was sent after the recall was expanded. The second letter dated March 6, 2009 was addressed to Safety/Risk Mangers, Healthcare Providers, Biomedical Engineers, Distributors, Clinicians and other Customers. The letter listed the Details of Affected Devices, Description of the Problem, Advise on Action to be Taken by the User, Results of Investigation and Contact Details.
• Quantity in Commerce: 2552
• Distribution: Worldwide, including USA, AMERICAN SAMOA, AUSTRALIA, CANADA, CHILE, GERMANY, UNITED KINGDOM, HONG KONG, IRELAND, ISRAEL, SOUTH KOREA, NETHERLANDS, SAUDI ARABIA, SWEDEN
• 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 and Original Applicant = MEDEX, INC.