Dynarex Specimen Containers recalled over sterility concerns

Recall date

March 3, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Dynarex Corporation recalls dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:…

Recall number

Z-2057-2016

FDA classification

Class II

Brand / firm

Dynarex Corporation

Sold / distributed

US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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