Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
Why it was 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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Recall record
- Recalling firm
- Smiths Medical ASD Inc.
- Product type
- Devices
- Recall number
- Z-0079-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Minneapolis, MN
- Recall initiated
- 2023-08-16
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0079-2024 · Source: openFDA enforcement.