Z-0707-2025 Class II Ongoing
FDA device recall Z-0707-2025 was initiated by Olympus Corporation Of The Americas on Nov 19, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 984 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 25, 2024
- Initiation Date
- Nov 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 984 units
Product Description
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 Pattern
AL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI. International distribution to Australia, Canada, Germany.
Code Information
Model Number: 240075. UDI: 00521925031883 (17)331015 (10)SM405666, Lot Number: SM405666. UDI: 00521925031883 (17)331015 (10)JB362646, Lot Number: JB362646.