Vista Dental Products Chlor-XTRA - 3mL Prefilled Syringes, QTY: 12, REF 503825
Check against the official notice below — it lists the full affected range.
Inter-Med LLC is recalling Vista Dental Products Chlor-XTRA 3mL prefilled syringes (Quantity 12 per package) because the affected lots may contain an incorrect rubber bung made of latex-free isoprene rubber material. When exposed to the bleach solution inside the syringes during storage, this rubber bung can degrade due to chemical interaction with the solution.
A total of 58 units were distributed to the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia. The affected products have lot/work order numbers 20190565 and 20191107 and can be identified by UDI (01)10818207020496. The recall notice does not specify what action affected consumers should take in response to 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: 58 units Lot/code info: UDI (01)10818207020496 Lot/Work Order Numbers: 20190565 20191107
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.