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Terminated

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

FDA Recall Z-2057-2016 · Posted None

Recalling FirmDynarex Corporation
Recall StatusTerminated
Product CodeNNI
Date Initiated2016-03-03
Date Terminated2018-06-06
Product Quantity399 cases/25 sleeves/20 cups & lids per sleeve

Reason for Recall

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

Firm Action

On March 2, 2016, dynarex Corporate Headquarters distributed Voluntary Device Recall notices and Recall Verification Forms to their customers via email. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to examine their stock immediately to determine if they have any of the lots listed on hand. If so, discontinue distributing and quarantine the product immediately. Promptly contact the Dynarex Credit & Return representative Avi Celnick (845-365-8200 Ext 6644) to arrange for product return. Customers account will be credited for all returned products. All customers are advised to complete the Voluntary Recall Verification Form and returm immediately via fax or e-mail to Vijay Sachdev (Fax 845-365-8238; [email protected]).

Root Cause

Labeling False and Misleading

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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