Nico Corp. recalls NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation…

Recall date

July 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2767-2015

FDA classification

Class II

Brand / firm

Nico Corp.

Sold / distributed

US Distribution to states of: MD, IN, CA, and NC.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.