Edwards Lifesciences, LLC: Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perf

Hazard

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

Details from the source

Reason for recall: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. Distribution: Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY, LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO, NEW YORK, Quantity: 847 Lot/code info: Lot Code: Model No; FEMII016AS; UDI: 0060913168341; All lots up to: BSLC1689 Serial Numbers: FEMII016AS FEMII016AS FEMII016AS

UPC codes

0060913168341

Source

Official record: FDA (Device enforcement) ↗

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