FDA DeviceClass II

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

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

From the FDA notice · Read the official notice ↗ · All Stryker recalls

What to do

The agency's notice has the remedy and who to contact.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
39,148
Illnesses reported
None reported
Manufactured in
1941 Stryker Way, N/A, Portage, MI, United States
Classification
Class II
Recall number
Z-0600-2026

In the FDA's words

Description
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. Product Number/UDI-DI (GTIN)/Lot Numbers: NN-1000 00816744021009 37AC5163 37AE9811 37AJ1438 37BJ0513 37CB3410 37CB3416 37CD6003 37CE3030 37EB5720 37FA4260 37GD2216 37GJ1603 37IC7023 37IJ0208 37JJ0122 37KI1300 37LA0158 37LI0320 37LJ1522; NN-1001 00816744021016 37AC5177 37AE9942 37AE9955 37AJ1439 37BJ0516 37CB3380 37CB3419 37CD6005 37CJ0204 37DE4864 37EB5721 37FA4261 37GD2219 37GJ1607 37IC7027 37IJ0209 37JD5753 37JJ0123 37KI1301 37LA0159 37LI0322 37LJ1525 Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands. Affected quantity: 39,148
Hazard
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

3 products in this recall

NICO surgical products recalled for latex in packaging tape

Stryker is recalling three NICO product lines: Myriad handpieces, Myriad illumination packs, and BrainPath Shephard's hooks. The packaging tape used to secure components contains latex, even though the products are labeled latex-free. Latex can cause an allergic reaction in people who are sensitive to it. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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