FDA-Device2016-07-06Class II

dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection

Dynarex Corporation
Hazard

Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.

Sold states
US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada
Affected count
399 cases/25 sleeves/20 cups & lids per sleeve
Manufactured in
10 Glenshaw St, Orangeburg, NY, United States
Products
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2057-2016

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