Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
FDA device recall Z-2735-2020 · posted 2020-08-06 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- Reason for recall
- Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 17019 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, K
- Date initiated
- 2020-06-26
- Date posted
- 2020-08-06
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) (K111386) | Smiths Medical MD, Inc. | 2011-08-29 |
| MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP (K040899) | Medex, Inc. | 2004-04-30 |