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Open, Classified

Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

FDA Recall Z-0968-2025 · Posted 2025-01-17

Recalling FirmAdept Medical Ltd
Recall StatusOpen, Classified
Product CodeETD
Date Initiated2024-11-24
Product Quantity310 units (160 US, 150 OUS)

Reason for Recall

Lack of 510(k) clearance.

Firm Action

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, [email protected] and Viv So, Technical File Manager [email protected] 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.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution. International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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