Recall Z-2734-2020 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
| Date | Aug 6, 2020 (initiated Jun 26, 2020) |
| Status | Open, Classified |
| Reason | Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. |
| Root cause | Software design |
| Action | Consignees are being contacted via direct mailing and email. Consignees are asked to review and complete the Recall Response form indicating understanding of notification. Distributors are asked to forward the notification to parties to whom product has been distributed. Smiths Medical will send out 2 additional notifications by email. Phone calls will be made to non-responders. |
| Quantity | 35616 units |
| Distribution | Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, S |
| FDA record | Open on fda.gov |