FDA recall Z-0015-2020

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-06-27

Report date

2019-10-09

Termination date

2021-08-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Racine, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0015-2020