Device Recall Sarns SoftFlow Aortic Cannulae

Part No. 7071, Lot #: 0658575, 0662312, 0666660, 0670324, 0670948, 0682566, 0686889, 0689725, 0695466, 0702123, 689725R; Part No. 7072, Lot #: 0658572, 0662311, 0670325, 0686126, 0687466, 0694421, 0702124, 694421R, 694445R; Part No. 7072X, Lot #: 0662871, 662871R, 684785R; Part No. 7080, Lot #: 0661085, 0670671, 0675676, 0687168, 0694423, 0696700, 0702127, 0711833, 694423R; Part No. 5767, Lot #: 0652211, 0661105, 0664361, 0670323, 0675826, 0677192, 0684996, 0685122, 0685123, 0689787, 0697471, 0708188, 0708770, 667914N, 689787R, 695467R; Part No. 5761, Lot #: 0650494, 0653427, 0661106, 0667066, 0668960, 0670940, 0672074, 0677795, 0678216, 0683309, 0685666, 0687798, 0689724, 0694428, 0696206, 0698338, 0703836, 0704646, 0708187, 0708767, 694428R; Part No. 5761X, Lot #: 0653824, 0660674, 0668570, 0674464, 0683051, 0686891, 686891R; Part No. 5767X, Lot #: 0662430, 0670967, 670967R; Part No. 6392, Lot #: 0648090, 0653418, 0659107, 0661101, 0664539, 0676371, 0677191, 0677794, 0685662, 0685663, 0685664, 0689718, 685664R, 689718R, 697473R; Part No. 6394, Lot #: 0650838, 0659106, 0661098, 0670945, 0674474, 0678011, 0685489, 0689720, 0696207, 0702122, 689720R; Part No. 5842, Lot #: 0654074, 0656644, 0671750, 0681809, 0688003, 0695986, 0710040, 688003R; Part No. 5798, Lot #: 0649217, 0656439, 0660663, 0662070, 0670425, 0677301, 0686890, 0688490, 0711274, 0711827, 688490R; Part No. 6393, Lot #: 684774R; Part No. 5768, Lot #: 0649874, 0654075, 0659017, 0662733, 0669800, 0670941, 0675738, 0677971, 0685665, 0687801, 0695468, 0708190, 687801R; Part No. 5762, Lot #: 0647163, 0650493, 0653424, 0659018, 0668571, 0670937, 0673175, 0674263, 0677300, 0678059, 0686324, 0689721, 0694413, 0702121, 0708189, 0708776, 694413R, 696147R; Part No. 5762X, Lot #: 0649168, 0661605, 696146R; Part No. 5768X, Lot #: 0661175, 0673743, 0677012, 677012R, 695469R; Part No. 6384, Lot #: 0649216, 0658580, 0666662, 0670943, 0674472, 0680716, 0687537, 0709686; Part No. 6386, Lot #: 0649585, 0653419, 0666613, 0668004, 0670938, 0676537, 0681103, 0687538, 0688901, 0709688, 688901R; Part No. 5843, Lot #: 0658532, 0677970, 0683959, 0687467, 0701580, 0710041, 687467R, 691572R. Part No. 5841, Lot #: 0660648, 0674761, 0677302, 0702132, 0711246, 690085R; Part No. 6387, Lot #: 0660256, 0695470, 660256R & Part No. 6385, Lot #: 653813.

Cardiovascular Devices

2

No

Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY and the countries of : Australia, Belgium, Canada, Chile, Japan, Malaysia, Mexico, Singapore, Taiwan, Thailand, United Arab Emirates (UAE) & United Kingdom.

Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating || Product Usage: || The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.