Reported Feb 28, 2018 · Terminated
Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
Ivoclar Vivadent, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 Vivadent, Inc. · 175 Pineview Dr · Amherst, NY · 14228-2231
Is this the product you have?
Heliomolar Refill 20x0.25g 140/A2Product code 541502ANCatalog number 541502
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 V37176, Exp. date: 15.10.2020 2 Batch: V40818, Exp. date: 13.11.2020 3 Batch: V45145, Exp. date: 05.12.2020 4 Batch: V51367, Exp. date: 22.01.2021 5 Batch: W00520, Exp. date: 29.01.2021 6 Batch: W01514, Exp. date: 04.02.2021 7 Batch: W07036, Exp. date: 05.03.2021 8 Batch: W13323, Exp. date: 07.04.2021 - Amount recalled
- 3,255 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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