Reported Oct 18, 2023 · Ongoing
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249;…
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- Medfusion Syringe Pump
- Model 3500-0600-XX
a) 0600-00b) 0600-01c) 0600-50d) 0600-51e) 0600-82f) 0600-249
- software versions
v3v4v5and v6
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 106105860412590600-00, UDI/DI 10610586041259 2 106105860412420600-01, UDI/DI 10610586041242 3 106105860432840600-50, UDI/DI 10610586043284 4 106105860432910600-51, UDI/DI 10610586043291 5 106105860430170600-82, UDI/DI 10610586043017 6 106105860412970600-249, UDI/DI 10610586041297; All serial numbers - Amount recalled
- 20383 pumps
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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