Recall Z-1004-2024 ยท ETD Tube, Tympanostomy
Olympus Corporation of the Americas
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
| Date | Feb 7, 2024 (initiated Dec 11, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Employee error |
| Action | 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 a |
| Quantity | 600 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932166 | SILICONE TYMPANOSTOMY TUBES Smith & Nephew Richards, Inc., Jul 26, 1993 |