Device product
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
Z-2057-2016
Product summary
- Event
- Event 73584
- Status
- Terminated
- Classification
- Class II
- Quantity
- 399 cases/25 sleeves/20 cups & lids per sleeve
- Official record key
device-enforcement:Z-2057-2016
Official wording
Reason: Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
Code information: Lot Numbers: 31899, 32014, 32015, 32410 & 32411
Distribution pattern: US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada
Derived failure modes
-
Unknown
Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.