Aizu Olympus Co., Ltd. Recall 93222
Description: Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Models: LF-DP LF-GP LF-TP
Aizu Olympus Co., Ltd. Recall 93222 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0338-2024 |
| Event ID | 93222 |
| Event Description | Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Models: LF-DP LF-GP LF-TP |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution. |
| Quantity | 65 units |
| Recall Reason | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection |
| Device Classification | 20231129 |
| Device Code Info | UDI-DI: LF-DP 04953170136856 LF-GP 04953170061998 LF-TP 04953170317576 |
| Center Classification Date | 20231117 |
| Recall Initiation Date | 20230925 |
| Recalling Firm | Aizu Olympus Co., Ltd. |
| Initial Notification | Letter |
| Similar To |