Edwards Lifesciences, Llc

Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73.  Serial numbers: VG000031 to VG007468

Cardiovascular Devices

2

No

Worldwide Distribution - Nationwide Distribution (USA) - and the countries of: Argentina, Australia/ New Zealand, Brazil, Canada, China, Columbia, Ecuador, Europe, Indonesia, Japan, Korea, Macao, Malaysia, Mexico, Middle East, Peru, Puerto Rico, Singapore, Thailand, Taiwan and Venezuela

Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, || 00.71, 00.73. || Product Usage: || The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requiring monitoring of hemodynamic parameters, including cardiac output, oximetry and right ventricular, ejection, fraction, and end diastolic volume.

Lot Numbers: 58822824; 58821774

Cardiovascular Devices

2

No

Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand

Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 || The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.

Model GEF09800 all units/serial numbers.

Gastroenterology-Urology Devices

2

No

Nationwide Distribution.

Edwards Lifesciences Aquarius System Model GEF09800.

58315682 58315684 58319564 58323527 58329182 58329183 58330839 58331170 58337676 58339525 58344788 58404076 58404077 58412886 58423180 58425421 58430853 58432662 58437558 58439309 58442706 58448659 58450729 58457786 58461586 517BC705 58475993 58481176 58483920 58488640 58492016 58495186 58495187 58502966 58507300 58515391 58517396 58521823 58524823 58527272 58530759 58537870 58537877 58551761 58568073 58578112 58578113 58580168 58581724 58588472 58592000 517BC706 58597273 58599730 58604851 58605887 58613048 58616823 58618748 58620574 58623035 58629084 58632507 58651514 58652960 58659509 58664309 58664309 58669996 58669998 58672855 58679236 58679860 58684904 58685420 58689629 58692796 58696610 517BC706A 58698652 58714764 515A1101 515A1102 515E3348 515H4785 515J5246 515K5874 515K5875 515L6221 516C8181 516D8613 516D8614 516E9154 516E9155 516F9635 516F9636 516G0232 516H0993 516H0994 516J1347 516J1348 516K1910 516K1911 516L2483 516L2484 516M2875 516M2876 517A3353 517A3354 517B3889 517B3890 517CC149 517CC150 517CC151 517CC889 517CC890 517CC891 517D4948 517E5557 517F6110 517F6111 517F6112 517G6621 517G6622 517G6623 517G6623A 517H7139 517H7140 6U11L2232

AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MS MO NC ND NE NH NJ NM NV NK OH OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico Australia, Belgium, Brazil, Bulgaria, Canada, Canary Island, China, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, India, Ireland, Italy, Japan, Luxembourg, Netherland, New Zealand, Poland, Portugal, Rumania, Russia, Singapore, Slovak Republic, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, and Turkey.

Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. || The product is intended for use in Temporary Vessel Occlusion.

Model Number: 1350BF85, Lot Numbers:  58501071, 58516969, 58545402, 58568606, 58584153, 58606248, 58624009, 58648809, 58503807, 58532828, 58549292, 58573256, 58594977, 58611630, 58626772, 58652695, 58511627, 58536781, 58552776, 58576340, 58598946, 58611631, 58630984, 58653740, 58516967, 58536782, 58559223, 58577684, 58602066, 58618047, 58636148, 58653741, 58516968, 58541155, 58559224, 58577685, 58606247, 5864008 and 58645016;  Model Number: 1351BF7, Lot Numbers: 58530069, 58545403, 58598947 and 58657088;  Model Number: 1351BF85H, Lot Numbers: 58526054, 58532992, 58534647, 58552777, 58559225, 58576341, 58594979, 58594980, 58598948, 58602067, 58624011, 58630985, 58636149, 58648810 and 58657097;  Model Number: 1450BF85, Lot Numbers: 58511628, 58516970, 58577686, 58589282, 58598949, 58615054, 58624015, 58635275 and 58664034; Model Number: 1451BF6, Lot Numbers: 58506614, 58526055, 58562341, 58577589, 58594981, 58615056, 58621700, 58635275, 58657143 and 58664035;  Model Number: 1451BF8, Lot Numbers: 58511629, 58514509, 58514513, 58530070, 58532829, 58541156, 58549294, 58556099, 58564225, 58568607, 58573257, 58584154, 58602069, 58606249, 58610319, 58615059, 58621701, 58648811, 58652696, 58660278 and 58685275;  Model Number: 1452BF85H, Lot Numbers: 58503809, 58549295, 58576343, 58611633, 58630986 and 586652697; Model Number: 1550BF6C, Lot Numbers: 58499574, 58501074, 58530071, 58532830, 58562343, 58602070, 58626774 and 58652698; Model Number: 1550BF7C, Lot Numbers: 58564227, 58577700 and 58657145; Model Number: 1550BF8, Lot Numbers: 58499575, 58526057, 58549298, 58560116, 58564228 and 58573260; Model Number: 1550BF85, Lot Numbers: 58501075, 58530072, 58534652, 58536809, 58577701, 58598950, 58618048 and 58657146; Model Number: 1551BF85H, Lot Numbers: 58615062, 58630987 and 58652699; Model Number: 1650BF85, Lot Numbers: 58545404, 58564229, 58584155, 58589283, 58618049, 58645018 and 58660284; Model Number: 1651BF85, Lot Numbers: 58499633, 58501080, 58511630, 58541157, 58556100, 58559226, 58584156, 58602071, 58615072, 58621702, 58645019 and 58652700; Model Number: 1652BF85H, Lot Numbers:  58511631, 58549300, 58606253 and 58648812; Model Number: S310740C, Lot Number: 58550203; and Model Number: S5507BF85, Lot Numbers: 58496258, 58535112, 58604814 and 58644423.

Cardiovascular Devices

2

No

Worldwide Distribution: United States (AL, AR, CA, CO, CT, DC, FL, GA, IA, IL, IN,KS, KY, MA, MD, ME, MI, MO, MS, ND, NH, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, VA, WV, HI and PR), Austria, Canada, Switzerland, Czech,republic, Germany, Denmark, Algeria, Estonia, Egypt, Spain, Finland, France, Great Britain, Hungary, Iceland, Ireland, Italy, Kuwait, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Sweden, Slovak republic, Tunisia, Turkey, Aruba, Hong Kong, Malaysia and Singapore.

Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. || Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion.