—#210995

Product

Duravent Silicone Ventilation Tube. Model Number: 240075.

FDA product code: ETD — Tube, Tympanostomy
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K932166
Affected lot / code info: Model Number: 240075. UDI: 00521925031883 (17)331015 (10)SM405666, Lot Number: SM405666. UDI: 00521925031883 (17)331015 (10)JB362646, Lot Number: JB362646.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

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.

Timeline

Recall initiated: 2024-11-19
Posted by FDA: 2024-12-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210995. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.