smiths medical Medfusion Model 3500 Syringe pump Recall
Issued February 7, 2024 · Smiths Medical ASD Inc.
In February 2024, Smiths Medical ASD Inc. recalled the smiths medical Medfusion Model 3500 Syringe pump, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps.
What you should do
- 1 Stop using smiths medical Medfusion Model 3500 Syringe pump right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Smiths Medical ASD Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Smiths Medical ASD Inc.
- Category
- Health
- Recall date
- February 7, 2024
- Units affected
- Not reported
- Sold at
- worldwide
- Recall number
- FDA-Z-0863-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Smiths Medical ASD Inc. has 4 recalls in our database, including 4 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.