FDA Enforcement
Class II
Ongoing
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Recall: Z-1004-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-1004-2024
- Event ID
- 93785
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- December 11, 2023
- Classification Date
- February 7, 2024
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
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 Info
UDI: 00821925031913 Lot Number: SM280573
Distribution
Worldwide distribution - US Nationwide and the countries of Australia.
Quantity
600 units