Recall Z-0963-2025 ยท ETD Tube, Tympanostomy
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
| Date | Jan 17, 2025 (initiated Nov 24, 2024) |
| Status | Open, Classified |
| Reason | Lack of 510(k) clearance. |
| Root cause | Device Design |
| 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. " Us |
| Quantity | 13,070 units (9090 US, 3980 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 Kong, Turkey, Chile, Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061058 | NEOZOLINE VENTILATION TUBES Adept Medical, Ltd., Jul 12, 2006 |