Recall Z-1019-2009 ยท FRN Pump, Infusion
Smiths Medical MD, Inc.
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 an
| Date | Mar 9, 2009 (initiated Dec 18, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root 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 Servic |
| Quantity | 2552 |
| Distribution | Worldwide, including USA, AMERICAN SAMOA, AUSTRALIA, CANADA, CHILE, GERMANY, UNITED KINGDOM, HONG KONG, IRELAND, ISRAEL, SOUTH KOREA, NETHERLANDS, SAUDI ARABIA, SWEDEN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP Medex, Inc., Apr 30, 2004 |