CLASS II Device recall · Reported 10 Jan 2018 · FDA Enforcement Report
Medfusion, Syringe Infusion Pump recalled by Smiths Medical ASD
Smiths Medical ASD is recalling Medfusion, Syringe Infusion Pump, distributed nationwide in the US. The recall was initiated on 22 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0313-2018
- FDA event ID
- 77761
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Aug 2017
- FDA classified
- 4 Jan 2018
- Reported
- 10 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 22 Aug 2017 | Recall initiated by company | |
| 4 Jan 2018 | Classified by FDA | +135 days |
| 10 Jan 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
Where it was distributed
Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
Questions about this recall
Why was it recalled?
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.
Which lots are affected?
Model No. 4000; Reference No. 4000-0101-51
Where was it sold?
Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 77761| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medfusion, Syringe Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Device Malfunction | Nationwide |
More recalls from Smiths Medical ASD
All 284| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Cadd Solis Hspca Pump ***Updated 5/27/26*** Scope updated recalled | Smiths Medical ASD | Device Malfunction | Nationwide |
| Device | CLASS I | Cadd-Solis Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
| Device | CLASS I | CADD Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Other | Nationwide |
| Device | CLASS I | Cadd-Solis VIP Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Device Malfunction | Nationwide |
| Device | CLASS I | Cadd-Solis Hpca Ambulatory Infusion Pump recalled by Smiths Medical ASD | Smiths Medical ASD | Device Malfunction | Nationwide |
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |