CLASS II ONGOING Device recall · Reported 18 Oct 2023 · FDA Enforcement Report
Medfusion Syringe Pump recalled by Smiths Medical ASD
Smiths Medical ASD is recalling Medfusion Syringe Pump, distributed nationwide in the US. The recall was initiated on 16 Aug 2023 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-0079-2024
- FDA event ID
- 92956
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Aug 2023
- FDA classified
- 6 Oct 2023
- Reported
- 18 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 16 Aug 2023 | Recall initiated by company | |
| 6 Oct 2023 | Classified by FDA | +51 days |
| 18 Oct 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
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 Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-78, i) 0105-249, j) 0106-00, k) 0106-01, l) 0106-231, m) 0107-01, software versions: v3, v4, v5, and v6
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Is Medfusion Syringe Pump recalled?
Yes. Smiths Medical ASD recalled Medfusion Syringe Pump on 16 Aug 2023. The recall is Class II and its status is Ongoing. Recall number Z-0079-2024.
Why was it recalled?
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
Which lots are affected?
a) 0100-50, UDI/DI 10610586035326; b) 0100-249, UDI/DI 10610586033124; c) 0101-50, UDI/DI 10610586040054; d) 0101-51, UDI/DI 10610586040818; e) 0101-78, UDI/DI 10610586040788; f) 0101-249, UDI/DI 10610586040078; g) 0105-51, UDI/DI 10610586043567; h) 0105-78, UDI/DI 10610586043574; i) 0105-249, UDI/DI 10610586043581; j) 0106-00, UDI/DI 15019517070750; k) 0106-01, UDI/DI 15019517069624; l) 0106-231, UDI/DI 15019517070996; m) 0107-01, UDI/DI 15019517154313; All serial numbers
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
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| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
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