Edwards Lifesciences, LLC: Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial 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: 558 Lot/code info: Lot Code: Model No: FEMII018AS; UDI: 00690103168358; All lots up to: BSLC9064 Serial Numbers: 131776 BSLC4190 BSLC9064

UPC codes

00690103168358

Source

Official record: FDA (Device enforcement) ↗

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