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

Recall date

June 27, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0015-2020

FDA classification

Class II

Brand / firm

Inter-Med Llc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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