Recall Z-0996-2013 ยท FRN Pump, Infusion
Smiths Medical ASD, Inc.
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
| Date | Mar 26, 2013 (initiated May 14, 2010) |
| Status | Terminated |
| Reason | An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions. |
| Root cause | Device Design |
| Action | On May 14th, 2010, Smiths Medical contacted the facility that received the pumps via e-mail and requested that they immediately return the pumps. The pumps were returned per Returned Goods Authorization (RGA) and exchanged for replacement pumps manufactured with plunger rod seal G6000077. |
| Quantity | 6 |
| Distribution | Distributed in the state of NH. |
| 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 |