Home / Recalls / Adept Medical Ltd / Z-0970-2025

Z-0970-2025 Class II Ongoing

Recalled by Adept Medical Ltd — Auckland

Recall Details

Product Type
Devices
Report Date
January 29, 2025
Initiation Date
November 24, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,080 units (1510 US, 2570 OUS)

Product Description

Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

Reason for Recall

Lack of 510(k) clearance.

Distribution Pattern

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.

Code Information

Product Code: NZ3321-2; UDI-DI: 09421901970413; Lots: 2015-4222, 2016-4893, 2016-5236, 2016-5408, 2017-5538, 2017-5790, 2017-6047, 2017-6233, 2018-6361, 2018-6735, 2019-6970, 2022-10451, 2023-11068.

Other recalls by Adept Medical Ltd

  • Z-0966-2025 Class II — Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309; (November 24, 2024)
  • Z-0969-2025 Class II — Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321; (November 24, 2024)
  • Z-0965-2025 Class II — Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ33 (November 24, 2024)
  • Z-0964-2025 Class II — Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ33 (November 24, 2024)
  • Z-0967-2025 Class II — Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312; (November 24, 2024)
  • Z-0963-2025 Class II — Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306 (November 24, 2024)
  • Z-0968-2025 Class II — Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3 (November 24, 2024)