EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (00690103174199), EZC24A (00690103714401), EZC24TA (00690103714418), EZF21A (00690103175080), EZF21TA (00690103175097), EZF24A (00690103175066), EZF24TA (00690103175073), EZS21A (00690103172096), EZS21TA (00690103172102), EZS24A (00690103172119), and EZS24TA (00690103172126) Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.

Detalles del retiro

Fabricante

Edwards Lifesciences, LLC

Distribuidor

Worldwide distribution - US Nationwide distribution in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming and countries of Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Chile, China, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hungary, Canary Islands, Ireland, India, Iceland, Italy, Japan, Mauritius, Malaysia, Netherlands, Norway, Poland, Romania, Sweden, Singapore, Slovakia, Thailand, Turkey, United Arab Emirates, South Africa.

Lote

Lot #s: 203876 207654 217024 226788,205724, 207655, 217025, 226938,205775, 208823, 217048, 227494,205868, 208893, 218185, 227886,205920, 208894, 218457, 228009,205921, 209901, 218539, 228259,205922, 209904, 219090, 228549,206369, 210110, 219212, 228558,206372, 210111, 219561, 229051,206373, 212032 ,220146 ,229054,206374, 212033 ,220151 ,229827,206768, 212034 ,220157 ,230690,206769, 212035 ,220802 ,230894,206770, 212258 ,220803 ,231105,206771, 212280 ,222841 ,231109,206772, 212959 ,222913 ,231111,206773, 213506 ,222914 ,231291,206774, 213914 ,222915 ,231485,206775, 214214 ,223174 ,232109,206776 ,214216 ,224233 ,232437,206777 ,214716 ,224235 ,234138,206778 ,214717 ,224662,207319 ,214961 ,224707,207320 ,215239 ,225306,207321 ,215495 ,225884,207322 ,216123 ,225885,207323 ,216196 ,226188,207324 ,216627 ,226596,207636 ,216628 ,226597,207638 ,216632, 226691

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States