Myriad-LX Light Source-for delivery of light to the recall
Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The…
Why was Myriad-LX Light Source-for delivery of light to the 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers 350-00194D 350-00355D 350-00356D 350-00357D 350-00376D through 350-00444D 350-00451D through 350-00460D 350-00463D through 350-00467D 350-004710 through 350-00475D
- Product
- Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection Part Number NN-7013 The…
- Recalling firm
- Nico Corp.
- Quantity
- 80 units
- Distribution
- US Nationwide Distribution
- Recall date
- June 16, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)