Olympus Corporation of the Americas Recall 93785
Description: Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Olympus Corporation of the Americas Recall 93785 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1004-2024 |
| Event ID | 93785 |
| Event Description | Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia. |
| Quantity | 600 units |
| Recall Reason | 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 |
| Device Classification | 20240214 |
| Device Code Info | UDI: 00821925031913 Lot Number: SM280573 |
| Center Classification Date | 20240207 |
| Recall Initiation Date | 20231211 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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