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

Olympus Corporation of the Americas: Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. 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: 231.4 units (5/box); 510 units (5/box) OUS Lot/code info: UDI-DI: 00821925044555 Lot Numbers: CA191233 CA191234 CA191235 CA233514 CA233515 CA233516 CA233517 CA233518 CA236206 CA236208 CA236213 CA236215 CA236216 CA236217 CA236220 CA236227 CA236228 CA236230 CA236238 CA236240 CA236243 CA236261 CA236272 CA236273 CA236276 CA236278 CA236290

UPC codes

00821925044555

Source

Official record: FDA (Device enforcement)

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

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