Device product
Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
Z-0017-2020
Product summary
- Firm
- Inter-Med Llc
- Event
- Event 83435
- Status
- Terminated
- Classification
- Class II
- Quantity
- 384 units
- Official record key
device-enforcement:Z-0017-2020
Official wording
Reason: 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.
Code information: Lot/Work Order Numbers: 2018-1471 2018-1992 20182211, UDI (01)10818207020502 20182779, UDI (01)10818207020502 20190041, UDI (01)10818207020502 20190309, UDI (01)10818207020502
Distribution pattern: US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Derived failure modes
-
Unknown
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.