Z-0965-2025Class II
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone
Adept Medical Ltd / initiated 2024-11-24 / Open, Classified / root cause: design
Adept Medical Ltd began a recall of Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2 on . FDA classified it as Class II and gives the reason as "Lack of 510(k) clearance". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0965-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Adept Medical Ltd
- Product
- Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
- Product code
- ETD Tube, Tympanostomy
- Reason for recall
- Lack of 510(k) clearance.
- Root cause tag
- design
- FDA 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. " 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.
- Quantity in commerce
- 2,610 units (240 US, 2370 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.
- Product codes and lots
- Product Code: NZ3309-2; UDI-DI: 09421901970376; Lots: 2009-1822, 2012-2723, 2013-3079, 2014-3452, 2014-3506, 2015-4277, 2016-4527, 2016-4664, 2016-4997, 2016-4997, 2017-5441, 2017-5674, 2017-6117, 2018-6458, 2018-6896, 2020-9591.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0963-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0964-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0965-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0966-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0967-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0968-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0969-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0970-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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