Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
FDA device recall Z-0970-2025 · posted 2025-01-17 · Open, Classified
Recall details
- Recalling firm
- Adept Medical Ltd
- Reason for recall
- Lack of 510(k) clearance.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- ETD
- Quantity affected
- 4,080 units (1510 US, 2570 OUS)
- Distribution
- 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
- Date initiated
- 2024-11-24
- Date posted
- 2025-01-17
- Location
- Auckland, Morningside, New Zealand
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEOZOLINE VENTILATION TUBES (K061058) | Adept Medical, Ltd. | 2006-07-12 |