Vista Dental Products Chlor-XTRA - 12mL Prefilled Syringes, QTY: 8, REF 503850
Check against the official notice below — it lists the full affected range.
Inter-Med LLC recalled Vista Dental Products Chlor-XTRA 12mL prefilled syringes because certain lots contained an incorrect rubber bung made of latex-free isoprene rubber. When exposed to the bleach solution inside the syringes during storage, this rubber material can degrade due to chemical interaction with the solution. A total of 384 units across four lot numbers (2018-1471, 2018-1992, 20182211, and 20190041, plus 20190309) were distributed to the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia.
The source document does not specify what consumers or healthcare providers should do with affected product.
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: 384 units Lot/code info: Lot/Work Order Numbers: 2018-1471 2018-1992 20182211, UDI (01)10818207020502 20182779, UDI (01)10818207020502 20190041, UDI (01)10818207020502 20190309, UDI (01)10818207020502
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.