Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Recall
- Recall Number
- Z-1004-2024
- Event Number
- 93785
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- ETD
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- December 11, 2023
- Posted
- February 7, 2024
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229
Description
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
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
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 [email protected].
Worldwide distribution - US Nationwide and the countries of Australia.
600 units