Otological Ventilation Tube (Adept Medical) – Clearance Issue (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Lack of 510(k) clearance.

Recommended Action

Per FDA guidance

On November 25, 2024 distributors were emailed URGENT MEDICAL ADVISORY RECALL NOTICES. We request that you please: 1. Complete the enclosed Recall Acknowledgement Form (even if you have no stock, please confirm via the No Stock tick box). 2. If you have stock, quarantine all stock of the above products. 3. Return the quarantined product to Adept Medical Ltd for credit processing as below. You should also check any stock held elsewhere in your organization. " If returning stock, please return stock with the completed Recall Acknowledgement Form to accompany the returned boxes. " Use our UPS account details as UPS :9F496F , postcode 2022 to process return freight " Send Completed Recall Acknowledgement Form to Yi Huang, Quality and Regulatory Manager, yhuang@adept.co.nz and Viv So, Technical File Manager vso@adept.co.nz We sincerely apologize for the inconvenience caused and assure you that the crediting of your returns will be treated as a matter of utmost urgency.