Nico Corp. recalls specific models of Myriad-LX Illumination Packs due to potential sleeve occlusion causing tissue injury during surgery. Affected units include lot numbers 37KII300 through 37IJ0209.
(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.
Nico Corp. is recalling certain Myriad-LX Illumination Packs that could cause tissue injury if the delivery sleeve becomes blocked during surgery. This risk is highest for surgical procedures where the sleeve might interact with tissue.
The delivery sleeve in the illumination pack can become blocked by tissue or debris, especially during endonasal procedures. This blockage may cause reduced light output and tissue injury if the sleeve is not replaced promptly.
Surgical teams using the recalled Myriad-LX Illumination Packs for procedures like endonasal surgery are most at risk. Patients and medical staff handling these packs during surgery could experience minor to moderate tissue injury.
Check for lot numbers 37KII300, 37KI1301, 37LI0320, 37LI0322, 37AJ1438, 37AJ1439, 37BJ0513, 37BJ0516, 37CJ0203, 37CJ0204, 37GJ1603, 37GJ1607, 37110208, or 37IJ0209 on the packaging.
If the delivery sleeve appears blocked or reduced light output occurs, replace both the delivery sleeve and fiber immediately.
Replace the delivery sleeve and fiber if occlusion is suspected to prevent tissue injury.
Lot numbers 37KII300, 37KI1301, 37LI0320, 37LI0322, 37AJ1438, 37AJ1439, 37BJ0513, 37BJ0516, 37CJ0203, 37CJ0204, 37GJ1603, 37GJ1607, 37110208, and 37IJ0209.
The delivery sleeve can become blocked by tissue or debris during surgery, especially in endonasal procedures, which may cause reduced light output and tissue injury.
Check the lot number on the packaging; affected units include the specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Nico Corp. to request your refund or repair — edit it as you like.
Subject: Recall Z-1839-2021 — Nico Corp. Nico Corp. Hello, I own a Nico Corp. that is covered by recall Z-1839-2021 from Nico Corp.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
