Recall Z-2057-2016 ยท NNI Container, Specimen, Non-Sterile
Dynarex Corporation
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
| Date | Mar 3, 2016 |
| Status | Terminated |
| Reason | Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton. |
| Root cause | Labeling False and Misleading |
| 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 al |
| Quantity | 399 cases/25 sleeves/20 cups & lids per sleeve |
| Distribution | US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.