medical Class II Updated 2019-10-09

Inter-Med Llc recalls Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-fi

Recalled Product

Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355

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: UDI (01)10818207020410 Lot/Work Order Numbers: 20182545 20182665 20190198 20190432 20190724 20190953 20191314
View official government recall

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