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U.S. Department of Health and Human Services

Class 2 Device Recall Nico

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  Class 2 Device Recall Nico see related information
Date Initiated by Firm April 30, 2021
Create Date June 09, 2021
Recall Status1 Terminated 3 on February 05, 2024
Recall Number Z-1839-2021
Recall Event ID 87882
510(K)Number K191599  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product 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.
Code Information Lot Numbers: 37KII300 37KI1301 37LI0320 37LI0322 37AJ1438 37AJ1439 37BJ0513 37BJ0516 37CJ0203 37CJ0204 37GJ1603 37GJ1607 37110208 37IJ0209
Recalling Firm/
Manufacturer		 Nico Corp.
250 E 96th St Ste 125
Indianapolis IN 46240-3872
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action The Firm, Nico Corporation, issued "URGENT: MEDICAL DEVICE RECALL" Letter dated 4/30/21 via email on 4/30/21. Letter states reason for recall, health risk and action to take: ACTIONS TO BE TAKEN BY YOU Illumination Pack Field Correction 1. Determine the current number of LX Illumination Packs at your facility with the lot numbers referenced above. 2. Locate the electronic version of the updated Instructions-for-Use for LX Illumination Packs that was provided with this letter via email (document number LL-5697 03). 3. Print the updated Instructions-for-Use in a quantity sufficient to cover all LX Illumination Packs at your facility with the lot numbers referenced above. 4. Replace the existing Instructions-for-Use (LL-5697_01) with the updated Instructions for-Use (LL-5697 03). 5. Discard the existing Instructions-for-Use (LL-5697_01). LX Light Source Removal 1. Your local NICO representative will notify when he/she will be on site to deliver the return _kit for retrieval of your LX Light Source. 2. Upon receipt of the return kit, remove your LX Light Source from use and package it using the materials provided within the kit. 3. Tape the box closed, affix the prepaid shipping label and deliver it to your shipping department. 4. Upon receipt of your LX Light Source, NICO will modify it and will then return it to your local NICO representative. He/she will then coordinate with you to return it to your facility. 5. Upon receipt of your modified LX Light Source, remove it from its packaging and begin using it again. 6. Locate and print the Response Form that was provided with this letter via email. 7. Complete the Response Form (including wet signature) and email it to jay.dittman@niconeuro.com. A scanned version or a photo of the Response Form is acceptable. NICO has opened a corrective action to address this issue. If you have any questions or need additional information, please contact me jay.dittman@niconeuro.com or 317-660-7118 ext. 204
Quantity in Commerce 439 packs
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = NICO Corporation
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