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U.S. Department of Health and Human Services

Class 2 Device Recall Adept Medical NeoZoline Ventilation Tube

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 Class 2 Device Recall Adept Medical NeoZoline Ventilation Tubesee related information
Date Initiated by FirmNovember 24, 2024
Date PostedJanuary 17, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0970-2025
Recall Event ID 95942
510(K)NumberK061058 
Product Classification Tube, tympanostomy - Product Code ETD
ProductOtological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
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.
FEI Number 3006098219
Recalling Firm/
Manufacturer		 Adept Medical Ltd
2-6 Mc Donald Street
Morningside, Po Box 10075 Dominion Rd
Auckland New Zealand
For Additional Information ContactBriar Wilson
+649815-2999
Manufacturer Reason
for Recall		Lack of 510(k) clearance.
FDA Determined
Cause 2		Device Design
ActionOn 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, yhuang@adept.co.nz and Viv So, Technical File Manager vso@adept.co.nz 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 Commerce4,080 units (1510 US, 2570 OUS)
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ETD
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