Reported Oct 14, 2020 · Terminated
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based,…
Ultradent Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ultradent Products, Inc. · 505 W 10200 S · South Jordan, UT · 84095-3800
Is this the product you have?
- PermaFlo
- Flowable Composite REF-UP 948 ShadeA2 -
- Product Usageis a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution
- Lot codes and dates
- Part Number - 948PermaFlo A2 Refill Lot Number - BJR5W UPC Code - 8832505103918 UDI Code - 00883205103918
- Amount recalled
- 412 syringes (206 kits)
Where it was sold
Why it was recalled
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
This product could cause temporary or reversible health problems — stop using it.
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