Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Summary
The FDA issued a Class II for Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: by Adept Medical Ltd. Reason: Lack of 510(k) clearance..
Details
Source
Device Recall
External ID
Z-0970-2025
Action Date
2025-01-29
Status
Ongoing
Category
device
Product Description
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Lot/Code Info: 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.
Quantity Affected: 4,080 units (1510 US, 2570 OUS)
Reason for Recall
Lack of 510(k) clearance.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-24
Company
Auckland
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Adept Medical Ltd has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Adept Medical Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Adept Medical Ltd have FDA actions?
Adept Medical Ltd has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0970-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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