FDA-Device2019-12-25Class II
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.
RHONDIUM LIMITED
Hazard
The product was mislabeled with an incorrect expiration date.
Sold states
Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution.
Affected count
6 devices
Manufactured in
4 Sheffield Street, Katikati, New Zealand
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0708-2020Don't want to check this manually?
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