dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
- Company
- Dynarex Corporation
- Recall Initiated
- March 3, 2016
- Terminated
- June 6, 2018
- Recall Number
- Z-2057-2016
- Quantity
- 399 cases/25 sleeves/20 cups & lids per sleeve
- Firm Location
- Orangeburg, NY
Reason for Recall
Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
Distribution
US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada
Lot / Code Info
Lot Numbers: 31899, 32014, 32015, 32410 & 32411
Root Cause
Labeling False and Misleading
Action Taken
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; v.sachdev@dynarex.com).