UltraSeal XT Plus Clear Refill recalled over labeling errors

Recall date

November 17, 2016

Source

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

Official notice title

Ultradent Products, Inc. recalls UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus…

Recall number

Z-0704-2017

FDA classification

Class II

Brand / firm

Ultradent Products, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide

Why it was recalled

There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.

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

What was recalled

UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.