medical Class II Updated 2021-09-08

Olympus Corporation of the Americas recalls Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgica

Recalled Product

Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC


Hazard / Issue

Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot number KR121617
View official government recall

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