FDA Enforcement
Class II
Ongoing
Duravent Silicone Ventilation Tube. Model Number: 240075.
Recall: Z-0707-2025
·
Reported December 25, 2024
Enforcement
- Recall Number
- Z-0707-2025
- Event ID
- 95716
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 25, 2024
- Initiation Date
- November 19, 2024
- Classification Date
- December 19, 2024
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
Duravent Silicone Ventilation Tube. Model Number: 240075.
Reason
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.
Code Info
Model Number: 240075. UDI: 00521925031883 (17)331015 (10)SM405666, Lot Number: SM405666. UDI: 00521925031883 (17)331015 (10)JB362646, Lot Number: JB362646.
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.
Quantity
984 units