Edwards Lifesciences, LLC recalls QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is pack

Recalled June 19, 2013 · FDA recall Z-1542-2013 · Edwards Lifesciences

Hazard

Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used. · FDA Class II

Units

22,616

Sold at

Worldwide distribution: US Nationwide and country of Canada.

Description

Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.

Product

QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one shipper carton. Use of the QuickDraw venous cannula is indicated for patients undergoing cardiopulmonary bypass. The QuickDraw venous cannula serves to drain non-oxygenated blood from the venae cavae or right atrium during cardiopulmonary bypass. The product is packaged sterile and nona¿ pyrogenic in a sealed, peel-type pouch.

Manufacturer(s)

Edwards Lifesciences, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →