World wide- USA states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. ---Foreign includes: Austria, Belgium, Denmark, France, Germany, Great Britain, Italy, Lichtenstein, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom
St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Sterile EO. St. Jude Medical Daig Division, Inc., Minnetonka, MN 55345-2126 USA. This St. Jude Medical (SJM) Agilis Steerable Catheter Introducer Set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise >than or equal to 180-degrees and counter-clockwise >than or equal to 90-degrees. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization. EXPANDED RECALL The Reorder number affected by the recall expansion is 408304.