Adept Medical Ltd Recall 95942
Description: Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Adept Medical Ltd Recall 95942 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0964-2025 |
| Event ID | 95942 |
| Event Description | Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2; |
| Product Type | Devices |
| 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. |
| Quantity | 2,010 units (630 US, 1380 OUS) |
| Recall Reason | Lack of 510(k) clearance. |
| Device Classification | 20250129 |
| Device Code Info | Product Code: NZ3306-2; UDI-DI: 09421901970352; Lots: 2009-1820, 2013-3195, 2014-3504, 2015-4220, 2016-4652, 2016-5211, 2019-6966, 2022-10349, |
| Center Classification Date | 20250117 |
| Recall Initiation Date | 20241124 |
| Recalling Firm | Adept Medical Ltd |
| Initial Notification | |
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