Recall Z-2057-2016— Dynarex Corporation
Class II · Terminated
Class II FDA medical device recall by Dynarex Corporation, initiated 2016-03-03, terminated 2018-06-06. FDA's recall record names no specific 510(k) clearance for this event. Product: dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection. Reason: Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton..
- Recalling firm
- Dynarex Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-03
- Terminated
- 2018-06-06
- Firm location
- Orangeburg, NY, United States
Product description
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
Reason for recall
Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
Data sourced from openFDA. This site is unofficial and independent of the FDA.