FDA Device

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.

Hazard

The product was mislabeled with an incorrect expiration date.

What You Should Do

Remedy

The firm called and emailed their U.S. customers on 1/31/2019 to notify them the device was labeled with the incorrect expiration date and was actually expiring that day.

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Products

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.
Brand
RHONDIUM LIMITED
UPC
Lot numbers 1832-1099 and 1828-0982.

Units Affected

6 devices

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