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[Recalled] Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins. — T

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductUltradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Brand / manufacturerUltradent Products, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-3216-2017
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date04 August 2017

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The barcode label was placed underneath the sterile barrier and the product was re-wrapped.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Ultradent Products, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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