Z-1004-2024 Class II Ongoing
FDA device recall Z-1004-2024 was initiated by Olympus Corporation of the Americas on December 11, 2023 and is designated Class II. Reason for recall: The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot The recall status is ongoing. Affected quantity: 600 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- December 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 600 units
Product Description
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Reason for Recall
The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia.
Code Information
UDI: 00821925031913 Lot Number: SM280573