Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The
FDA device recall Z-0610-2020 · posted 2019-12-12 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 626 devices
- Distribution
- CO, MD, NY
- Date initiated
- 2019-10-28
- Date posted
- 2019-12-12
- Date terminated
- 2024-06-06
- Location
- Minneapolis, MN
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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 |