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.
Check against the official notice below — it lists the full affected range.
Ultradent Products, Inc. is recalling PermaFlo Flowable Composite in Shade A2 (Part Number 948, Lot Number BJR5W) due to a manufacturing issue involving cross contamination that resulted in a non-homogeneous composite. The affected product includes 412 syringes distributed worldwide across numerous U.S. states as well as Australia, Germany, Japan, and Mongolia.
The source document does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Reason for recall: Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, IN, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI. The countries of Australia, Germany Japan and Mongolia. Quantity: 412 syringes (206 kits) Lot/code info: Part Number - 948: PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.