Recall Z-1839-2021 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
| Date | Apr 30, 2021 |
| Status | Terminated |
| Reason | (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 |
| Root cause | 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 al |
| Quantity | 439 packs |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191599 | NICO Myriad NOVUS Nico Corporation, Sep 13, 2019 |