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Nico Corp. recalls NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellat
Recalled September 23, 2015 · FDA recall Z-2767-2015 · Nico
Hazard
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. · FDA Class II
Units
6 units
Sold at
US Distribution to states of: MD, IN, CA, and NC.
Description
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.
Product
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.
Manufacturer(s)
Nico Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →