Reported Oct 4, 2017 · Terminated

Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile. Product Usage: The product is used…

Ultradent Products, Inc.

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: Ultradent Products, Inc. · 505 W 10200 S · South Jordan, UT · 84095-3800

Is this the product you have?

  • Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile
  • Product UsageThe product is used to assure that all moisture is removed from the root canal before the obturation procedure begins
Lot codes and dates
  • Lot numbers BCDZQ, BCPRC, and BD3MT
Amount recalled
61 units

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

The barcode label was placed underneath the sterile barrier and the product was re-wrapped.

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 Jan 4, 2018 · Data as of Sep 19, 4:12 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.