Recall Z-0610-2020 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
| Date | Dec 12, 2019 (initiated Oct 28, 2019) |
| Status | Terminated |
| Reason | There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy. |
| Root cause | Software design |
| Action | An Urgent Medical Device recall letter dated 10/28/2019 was sent to customers via email beginning 10/28/2019. The letter identified affected product, stated the issue, and provided instructions for customers to return the pumps. A response form was asked to be returned. Questions can be directed to fieldactions@smiths-medical.com. |
| Quantity | 626 devices |
| Distribution | CO, MD, NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111386 | MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) Smiths Medical MD, Inc., Aug 29, 2011 |