Otological Ventilation Tube - Donaldson - Blue Silicone recall
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Why was Otological Ventilation Tube - Donaldson - Blue Silicone recalled?
Lack of 510(k) clearance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: NZ3321; UDI-DI: 09421901970406; Lots: 2017-5547, 2018-6609, 2023-10988, 2015-4105, 2016-4595, 2016-4760, 2016-5201, 2017-5536, 2017-5547, 2018-6609, 2019-7331, 2023-10988, 2023-11130.
- Product
- Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
- Recalling firm
- Adept Medical Ltd
- Quantity
- 2,440 units (1940 US, 500 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.
- Recall date
- January 29, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)