Z-0015-2020 Class II Terminated
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
- 445 units
Product Description
Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
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)10818207020410 Lot/Work Order Numbers: 20182545 20182665 20190198 20190432 20190724 20190953 20191314