FDAJune 19, 2018device
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and expiration date, etc
What to do
FDA enforcement status: Terminated
Brands named
nico
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination Pack. l3ga Intended to perform resection and removal of soft tissues and fluids under direct visualization accessories to the NICO Myriad System.2021-04-30
- FDAMyriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The Myriad-LX light source is a high-intensity 300W Xenon illuminator with a touch screen and digital dimming controls. The source is fitted with a proprietar...2021-04-30
- FDANICO 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, laparoscopi...2015-07-29
- FDAMyriad handpiece Tissue morcellator2014-02-24
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