—#205442

Product

Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044

FDA product code: ETD — Tube, Tympanostomy
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K932166
Affected lot / code info: UDI: 00821925031913 Lot Number: SM280573

Why it was recalled

The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot

Root cause (FDA determination)

Employee error

Action the firm took

Olympus (Gyrus ACMI, Inc.) issued Urgent Medical Device Removal letter on 12/11/23. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory and identify any products of the model and lot subject to this action. Please check all areas of your facility to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lot. 2. Please contact Olympus Customer Service at 1-800-848-9024, option 2, with the quantity and model of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall. b. Enter the recall number "0436 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia.

Timeline

Recall initiated: 2023-12-11
Posted by FDA: 2024-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205442. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.