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Aizu Olympus Co., Ltd. recalls Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronch

Recalled November 29, 2023 · FDA recall Z-0339-2024 · Aizu Olympus

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 · FDA Class II
Units
61 units
Sold at
Worldwide - US Nationwide distribution.

Description

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

Product
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
Manufacturer(s)
Aizu Olympus Co., Ltd.
Made in
Japan

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Aizu Olympus Co., Ltd. recalls Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronch | RecallWatchUSA