FDA Enforcement Class II Completed

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.

Recall: Z-0708-2020 · Reported December 25, 2019

Enforcement

Recall Number: Z-0708-2020
Event ID: 84126
Classification: Class II
Status: Completed
Product Type: Devices
Firm: RHONDIUM LIMITED
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date: December 25, 2019
Initiation Date: January 31, 2019
Classification Date: December 19, 2019
Address: 4 Sheffield Street, Katikati, N/A, New Zealand

Reason

The product was mislabeled with an incorrect expiration date.

Code Info

Lot numbers 1832-1099 and 1828-0982.

Distribution

Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution.

Quantity

6 devices