medical Class II Updated 2019-10-09

Inter-Med Llc recalls Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pr

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
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
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