Reported Jun 16, 2021 · Terminated
NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination…
Nico Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nico Corp. · 250 E 96th St Ste 125 · Indianapolis, IN · 46240-3872
Is this the product you have?
- NICO Myriad-LX Illumination PackREF: NN-1000 Mvriad-LX Illumination Pack. 11ga
- REFNN-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
- Lot codes and dates
- Lot Numbers
37KII30037KI130137LI032037LI032237AJ143837AJ143937BJ051337BJ051637CJ020337CJ020437GJ160337GJ16073711020837IJ0209
- Lot Numbers
- Amount recalled
- 439 packs
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
(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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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