FDAClass IIDecember 25, 2019

Rhondium OVC3 One Visit Crown recall: Labeling Error

Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.

Why was Rhondium OVC3 One Visit Crown recalled?

The product was mislabeled with an incorrect expiration date.

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?

Lot numbers 1832-1099 and 1828-0982.

Product
Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.
Recalling firm
RHONDIUM LIMITED
Quantity
6 devices
Distribution
Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution.
Recall date
December 25, 2019
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls