Reported Dec 14, 2016 · Terminated
UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus…
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?
- UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus
- Product UsageThe 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
- Lot codes and dates
- Lot BD79T
- Amount recalled
- 31
Where it was sold
- 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.
This product could cause temporary or reversible health problems — stop using it.
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