FDA recall Z-1004-2024

Olympus Corporation of the Americas · Class II · device

Product

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

Worldwide distribution - US Nationwide and the countries of Australia.

Key facts

Status: Ongoing
Initiation date: 2023-12-11
Report date: 2024-02-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1004-2024