Adept Medical Ltd Recall 95942
Description: Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd Recall 95942 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0966-2025 |
| Event ID | 95942 |
| Event Description | Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309; |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of IL, MO. |
| Quantity | 5,320 units (2370 US, 2950 OUS) |
| Recall Reason | Lack of 510(k) clearance. |
| Device Classification | 20250129 |
| Device Code Info | Product Code: NZ3309; UDI-DI: 09421901970369; Lots: 2008-1459; 2009-1864; 2011-2331, 2012-2961, 2013-3122, 2013-3363, 2014-3783, 2014-3832, 2015-3943, 2016-4601, 2016-5197, 2017-5651, 2017-6150, 2018-6487, 2018-6818, 2019-7211, 2021-10033, 2022-10783, 2023-11053, |
| Center Classification Date | 20250117 |
| Recall Initiation Date | 20241124 |
| Recalling Firm | Adept Medical Ltd |
| Initial Notification | |
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