Inter-Med Llc: Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300

Is my product affected?

Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300

• UPC 10818207020465

Check against the official notice below — it lists the full affected range.

What happened

Inter-Med LLC is recalling Vista Dental Products Sodium Hypochlorite 6% in 10-12cc pre-filled syringes because certain affected lots contain an incorrect rubber bung made of latex-free isoprene rubber material. When exposed to the bleach solution during storage, this rubber material can degrade due to chemical interaction, potentially compromising the product's integrity. The recall affects 1,992 units distributed in the US, South Africa, Switzerland, Poland, Italy, Singapore, and Australia across five specific lot/work order numbers: 2018-1348, 2018-1585, 2018-1586, 2018-1852, and 2018-2106, along with associated lots 2018-2302, 2018-2458, 2019-0725, and 2019-0835.

The source document does not specify what an affected consumer should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: 1992 units Lot/code info: Lot/Work Order Numbers: 2018-1348 2018-1585 2018-1586 2018-1852 20182106, UDI (01)10818207020465 20182302, UDI (01)10818207020465 20182458, UDI (01)10818207020465 20190725, UDI (01)10818207020465 20190835, UDI (01)10818207020465

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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