Reported Oct 9, 2019 · Terminated

Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga…

Inter-Med LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Inter-Med Llc · 2200 Northwestern Ave · Racine, WI · 53404-2500

Is this the product you have?

  • 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
Lot codes and dates
  • No UDI Lot/Work Order Numbers2018-1192 2018-1473 2018-1742 2018-1999 2018-2386 2018-2741 2019-0047
Amount recalled
377 units

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 10, 2021 · Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.