Reported Aug 12, 2020 · Ongoing
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Smiths Medical ASD Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 4000Software Versions V1.5.0V1.5.1V1.6.0and V1.6.1
- Lot codes and dates
- Model Numbers
4000-0105-2494000-0105-504000-0105-514000-0105-784000-0106-004000-0106-01and 4000-0106-231. Software Versions V1.5.0V1.5.1V1.6.0and V1.6.1
- Model Numbers
- Amount recalled
- 35616 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Stop using this product now
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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