Reported Nov 11, 2015 · Terminated
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental…
Ivoclar A. G.
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: Ivoclar A. G. · Fl-9494 · Schaan, N/A · N/A
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
| — | Refill 1 x 1.25 g |
558519AN | and Helioseal F Assortment (kit) 5 x 1.25 g |
558518AN. | Dental sealant. -- ivoclar vivadent clinical --- Helioseal F |
| — | Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca. |
- Lot codes and dates
Lot U12511Kit Lot U19925 (Helioseal F Assortment only)exp. 11.09.2017
- Amount recalled
- Domestic: 337 units
Where it was sold
Why it was recalled
A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.
This product could cause temporary or reversible health problems — stop using it.
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