Home / Recalls / Olympus Corporation of the Americas / Z-2380-2021

Z-2380-2021 Class II Terminated

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
September 8, 2021
Initiation Date
June 9, 2021
Termination Date
February 17, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 boxes (5 per/box)=30 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution in the states of CA, GA, MN, TN.

Code Information

Lot number KR121617

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