Z-0014-2020 Class II Terminated
FDA device recall Z-0014-2020 was initiated by Inter-Med Llc on June 27, 2019 and is designated Class II. Reason for recall: The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained … The recall status is terminated (terminated August 10, 2021). Affected quantity: 768 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2019
- Initiation Date
- June 27, 2019
- Termination Date
- August 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 768 units
Product Description
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Reason for Recall
The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
Distribution Pattern
US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Code Information
UDI (01)10818207020458 Lot/Work Order Numbers: 20190197 20190723 20190834 20190862 20190952