Z-0017-2020 Class II Terminated
FDA device recall Z-0017-2020 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: 384 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
- 384 units
Product Description
Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
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: 2018-1471 2018-1992 20182211, UDI (01)10818207020502 20182779, UDI (01)10818207020502 20190041, UDI (01)10818207020502 20190309, UDI (01)10818207020502