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FDA (Device enforcement)Recalled 2022-08-12class ii

Olympus Corporation of the Americas: Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive

Hazard

An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment

Details from the source

Reason for recall: An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment Distribution: Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA Quantity: 27 units (5/box) US; 83 units(5/box) OUS Lot/code info: UDI-DI: 00821925044531 Lot Numbers: CA191167 CA191168 CA191169 CA191170

UPC codes

00821925044531

Source

Official record: FDA (Device enforcement)

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

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