Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Check against the official notice below — it lists the full affected range.
Inter-Med LLC is recalling Vista Dental Products Sodium Hypochlorite 3% in 10-12cc pre-filled syringes because some units may contain an incorrect rubber bung made of latex-free isoprene rubber. When exposed to the bleach solution inside the syringe during storage, this rubber material can degrade due to chemical interaction with the solution. The recall affects 582 units distributed across the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia across seven specific lot and work order numbers.
The recall applies to syringes with lot/work order numbers 2018-1349, 2018-1587, 2018-1853, 2018-2107, 2018-2303, 2018-2584, 2018-2666, 2019-0199, and 2019-0433. The source record does not specify what consumers or healthcare facilities should do if they have affected products.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: US, South Africa, Switzerland, Poland, Italy, Singapore, Australia Quantity: 582 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.