Aizu Olympus Co., Ltd.: Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, L

Hazard

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

Details from the source

Reason for recall: 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 Distribution: Worldwide - US Nationwide distribution. Quantity: 65 units Lot/code info: Model Number (UDI-DI): LF-DP (04953170136856), LF-GP (04953170061998), LF-TP (04953170317576).

UPC codes

04953170136856, 04953170061998, 04953170317576

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.