FDA-Device2019-10-09Class II
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Inter-Med Llc
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.
Sold states
US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Affected count
1992 units
Manufactured in
2200 Northwestern Ave, N/A, Racine, WI, United States
Products
Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0012-2020Don't want to check this manually?
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