PlainRecalls
FDA Devices Moderate Class II Ongoing

Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044

Reported: February 14, 2024 Initiated: December 11, 2023 #Z-1004-2024

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

Details

Units Affected
600 units
Distribution
Worldwide distribution - US Nationwide and the countries of Australia.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044. Recalled by Olympus Corporation of the Americas. Units affected: 600 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-1004-2024.