Home / Recalls / Nico Corp. / Z-1839-2021

Z-1839-2021 Class II Terminated

Recalled by Nico Corp. — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
June 16, 2021
Initiation Date
April 30, 2021
Termination Date
February 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
439 packs

Product Description

NICO 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.

Reason for Recall

(1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical.field to prevent complete occlusion. Some surgical approaches (e.g., endonasal) may increase this potential. {f unintended reduction in light output occurs and/or occlusion of the sleeve is suspected, both the delivery sleeve and the fiber should be replaced (2) Removal for the LX Light Source potential for the distal tip of the sleeve/fiber assembly potential to burn healthy tissue resulting in minor to moderate injury to the patient or end user.

Distribution Pattern

US Nationwide Distribution

Code Information

Lot Numbers: 37KII300 37KI1301 37LI0320 37LI0322 37AJ1438 37AJ1439 37BJ0513 37BJ0516 37CJ0203 37CJ0204 37GJ1603 37GJ1607 37110208 37IJ0209

Other recalls by Nico Corp.

  • Z-1840-2021 Class II — Myriad-LX Light Source-for delivery of light to the surgical field to enhance vi (April 30, 2021)
  • Z-2822-2018 Class II — NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath dev (June 19, 2018)
  • Z-2767-2015 Class II — NICO Myriad Console Model number NN-7000 The Myriad System is a surgical sy (July 29, 2015)
  • Z-2045-2016 Class II — Myriad handpiece Tissue morcellator (February 24, 2014)
  • Z-2201-2012 Class II — 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products t (July 17, 2012)
  • Z-2200-2012 Class II — 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products t (July 17, 2012)