Ultradent Products, Inc. recalls Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used…

Recall date

August 4, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3216-2017

FDA classification

Class II

Brand / firm

Ultradent Products, Inc.

Sold / distributed

Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was 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.