Z-0013-2020 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
- 582 units
Product Description
Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
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
Lot/Work Order Numbers: 2018-1349 2018-1587 2018-1853 20182107, UDI (01)10818207020427 20182303, UDI (01)10818207020427 20182584, UDI (01)10818207020427 20182666, UDI (01)10818207020427 20190199, UDI (01)10818207020427 20190433, UDI (01)10818207020427