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

FDA device recall Z-1004-2024 · posted 2024-02-07 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

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

Action taken

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.

Root cause

Employee error

Status

Open, Classified

Product code

ETD

Quantity affected

600 units

Distribution

Worldwide distribution - US Nationwide and the countries of Australia.

Date initiated

2023-12-11

Date posted

2024-02-07

Location

Center Valley, PA

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