Reported May 29, 2019 · Terminated
EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid…
Edwards Lifesciences, LLC
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: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- EV1000 Clinical Platform
- Models
EV1000AEV1000NI
- EV1000CS Product UsageEV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor)
- Lot codes and dates
- All lots
- Amount recalled
- 22443
Where it was sold
Why it was recalled
Stop using this product now
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
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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