Recall Z-0964-2025— Adept Medical Ltd
Class II · Ongoing
Class II FDA medical device recall by Adept Medical Ltd, initiated 2024-11-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;. Reason: Lack of 510(k) clearance..
- Recalling firm
- Adept Medical Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-24
- Firm location
- Auckland, New Zealand
Product description
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Reason for recall
Lack of 510(k) clearance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.