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FDA (Device enforcement)Recalled 2023-09-12class ii

Olympus Corporation of the Americas: THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecolog

Hazard

Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

Details from the source

Reason for recall: Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery Distribution: US Nationwide distribution. Quantity: 271 units Lot/code info: UDI-DI: 4953170409684 Lot Numbers: KR310806 KR310809 KR313734 KR319658 KR326619 KR326628 KR333661 Lots Added January 11, 2024: KR310806 KR310809 KR333661 KR342666

UPC codes

4953170409684

Source

Official record: FDA (Device enforcement)

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

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