Device product
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Z-1004-2024
Product summary
- Event
- Event 93785
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 600 units
- Official record key
device-enforcement:Z-1004-2024
Official wording
Reason: 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
Code information: UDI: 00821925031913 Lot Number: SM280573
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia.
Derived failure modes
-
Unknown
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