Nico Corp. 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

(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.

Recommended Action

Per FDA guidance

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