medical Class II Updated 2020-10-14

Ultradent Products, Inc. recalls PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product U

Recalled Product

PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.


Hazard / Issue

Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →