Reported Sep 23, 2015 · Terminated
NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation…
Nico Corp.
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: Nico Corp. · 250 E 96th St · Indianapolis, IN · 46240-3781
Is this the product you have?
- NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.
- Lot codes and dates
- Model number NN-7000 SN
002310023200242002450024800250
- Model number NN-7000 SN
- Amount recalled
- 6 units
Where it was sold
Why it was recalled
Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. When these wires break or contact one another (i.e., short), various types of malfunction may occur with the console. One type of malfunction may result in unexpected aspiration increase.
This product could cause temporary or reversible health problems — stop using it.
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