FDA-Device2025-12-03Class IIMISBRANDING

NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber

LABEL MIX UPNationwide distributionMedical devices
Hazard

Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.
Affected count
39,148
Manufactured in
1941 Stryker Way, N/A, Portage, MI, United States
Products
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0600-2026

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