medical Class II Updated 2019-10-09

Inter-Med Llc recalls Vista Dental Products CanalClean Endodontic Irrigation Kit,

Recalled 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


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: No UDI Lot/Work Order Numbers: 2018-1192 2018-1473 2018-1742 2018-1999 2018-2386 2018-2741 2019-0047
View official government recall

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