FDA recall Z-0707-2025

Olympus Corporation of the Americas · Class II · device

Product

Duravent Silicone Ventilation Tube. Model Number: 240075.

Reason for recall

Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.

Distribution

AL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI. International distribution to Australia, Canada, Germany.

Key facts

Status
Ongoing
Initiation date
2024-11-19
Report date
2024-12-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0707-2025