Z-0012-2020 Class II Terminated
FDA device recall Z-0012-2020 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: 1992 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
- 1992 units
Product Description
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
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: 2018-1348 2018-1585 2018-1586 2018-1852 20182106, UDI (01)10818207020465 20182302, UDI (01)10818207020465 20182458, UDI (01)10818207020465 20190725, UDI (01)10818207020465 20190835, UDI (01)10818207020465