Device product
Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
Z-0015-2020
Product summary
- Firm
- Inter-Med Llc
- Event
- Event 83435
- Status
- Terminated
- Classification
- Class II
- Quantity
- 445 units
- Official record key
device-enforcement:Z-0015-2020
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: UDI (01)10818207020410 Lot/Work Order Numbers: 20182545 20182665 20190198 20190432 20190724 20190953 20191314
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.