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Inter-Med Llc recalls Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350

Recalled October 9, 2019 · FDA recall Z-0014-2020 · Inter-Med

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. · FDA Class II
Units
768 units
Sold at
US, South Africa, Switzerland, Poland, Italy, Singapore, Australia

Description

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.

Product
Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Manufacturer(s)
Inter-Med Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Inter-Med Llc recalls Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350 | RecallWatchUSA