FDA recall Z-0011-2020

Inter-Med Llc · Class II · device

Product

Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700

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-0011-2020