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

Olympus Corporation of the Americas: Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. 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: 44 units (5/box); 133 units (5/box) OUS Lot/code info: UDI-DI: 00821925044579 Lot Numbers: CA191182 CA191183 CA191184 CA191185 CA191186 CA236235 CA236237 FR230559

UPC codes

00821925044579

Source

Official record: FDA (Device enforcement)

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

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