Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Check against the official notice below — it lists the full affected range.
Inter-Med LLC is recalling Vista Dental Products Sodium Hypochlorite 6% pre-filled syringes due to packaging defects. The affected syringes contain an incorrect rubber bung made of latex-free isoprene rubber material that can degrade when exposed to the bleach solution inside during prolonged storage. This degradation occurs due to chemical interaction between the rubber and the bleach solution. The recall affects 768 units distributed in the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia across specific lot numbers: 20190197, 20190723, 20190834, 20190862, and 20190952.
The recall notice does not specify a remedy or recommended action for consumers who may have purchased or received 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: 768 units Lot/code info: UDI (01)10818207020458 Lot/Work Order Numbers: 20190197 20190723 20190834 20190862 20190952
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.