Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355
Check against the official notice below — it lists the full affected range.
Vista Dental Products 3% Sodium Hypochlorite syringes from Inter-Med LLC are being recalled due to a packaging defect. The affected syringes contain an incorrect rubber bung made of latex-free isoprene rubber material. The problem involves specific lot numbers (20182545, 20182665, 20190198, 20190432, 20190724, 20190953, and 20191314), with a total of 445 units distributed across the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia.
The defect occurs when the rubber bung degrades due to chemical interaction between the isoprene rubber material and the bleach solution stored inside the syringe during prolonged storage and exposure. The source does not specify what actions affected consumers should take regarding this recall.
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: 445 units Lot/code info: UDI (01)10818207020410 Lot/Work Order Numbers: 20182545 20182665 20190198 20190432 20190724 20190953 20191314
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.