Silex Medical, LLC: Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033.

Hazard

Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

Details from the source

Reason for recall: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel. Distribution: US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii. Quantity: 2 units Lot/code info: Model/REF Number: 5881033. UDI-DI: B33158810330. Lot Number: M28188. Serial Numbers: 0107, 0108.

Source

Official record: FDA (Device enforcement) ↗

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