FDAClass IIIFebruary 28, 2018

Heliomolar recall

Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

Why was Heliomolar 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch: V35109 Exp. date: 01.10.2020; Batch: V40817 Exp. date: 13.11.2020; Batch: V48597 Exp. date: 30.12.2020; Batch: V48938 Exp. date: 31.12.2020 Batch: W12251 Exp. date: 31.03.2021

Product
Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
Recalling firm
Ivoclar Vivadent, Inc.
Quantity
2,153 units
Distribution
US and Canada
Recall date
February 28, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls