Duravent Silicone Ventilation Tube. Model Number: 240075.
FDA device recall Z-0707-2025 · posted 2024-12-19 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- 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.
- Action taken
- Olympus notified consignees on 11/19/2024 via Courier, 2-day delivery. Consignees were instructed to examine inventory for affected devices, quarantine any affected devices on hand, arrange for return of those affected units and acknowledge receipt of the customer letter through the web portal.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- ETD
- Quantity affected
- 984 units
- 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.
- Date initiated
- 2024-11-19
- Date posted
- 2024-12-19
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILICONE TYMPANOSTOMY TUBES (K932166) | Smith & Nephew Richards, Inc. | 1993-07-26 |