Reported Jan 25, 2017 · Terminated

NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain…

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?

    • NanoTips 30g 20pk
    • 100pk PN 1240
    • 1426
  • DescriptionNanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive
  • IndicationsTips, when used in conjunction with the range of available syringes and products, provide a technique that is designed to provide a faster, easier, and more precise delivery. They are designed and created in such a way to generate less product waste and provide optimum control/leverage. Tips are also used for moisture removal and for directing laser light beam. Each of the tips is part of delivery systems designed for dentist-supervised, intra-oral procedures. The NanoTIp is designed for use with dental products manufactured by Ultradent Products, Inc
  • such asUltraSeal XT¿ plus, UltraSeal XT¿ hydro, Ultra-Etch¿, PermaFloIdeal for microscopic restorative dentistry
Lot codes and dates
  • Lot NumbersBD6KM, BCVPG, BCTBY, BD3K4, BCWVZ
Amount recalled
143 packs of 100 tips; 104 packs of 20 tips

Where it was sold

  • Nationwide

Why it was recalled

Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.

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 Jun 5, 2017 · Data as of Sep 19, 4:12 PM UTC

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