190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Recall details

Manufacturer

Fresenius Medical Care Holdings, Inc.

Distributor

Domestic: Nationwide Distribution. International: Canada.

Lot

Model Number: 190395; UDI/DI: 00840861100958; Serial Number: 6K0S-985P, 7K0S107747, 6K0S-021M, 7K0S103530, 6K0S-780R, 6K0S-192E, 6K0S-217E, 7K0S102986, 7K0S110138, 7K0S110142, 7K0S106422, 4K0S-P981, 4K0S-N154, 4K0S-N157, 4K0S-Q697, 5K0S-V190, 5K0S-V199, 6K0S-012R, 4K0S-M705, 4K0S-M708, 4K0S-N842, 4K0S-N843, 4K0S-N846, 4K0S-N850, 4K0S-N913, 4K0S-P289, 4K0S-P290, 4K0S-P298, 4K0S-P299, 4K0S-R079, 4K0S-R106, 4K0S-R114, 4K0S-R082, 4K0S-R136, 4K0S-S707, 4K0S-S708, 4K0S-S716, 6K0S-320H, 6K0S-325H, 6K0S-332H, 4K0S-S713, 5K0S-309C, 4K0S-M703, 4K0S-N847, 4K0S-R080, 4K0S-L722, 4K0S-N152, 4K0S-N155, 4K0S-N159, 4K0S-P291, 4K0S-P294, 4K0S-P295, 4K0S-Q694, 4K0S-Q688, 4K0S-R107, 4K0S-R081, 5K0S-T891, 4K0S-R135, 7K0S106375, 5K0S-168D, 5K0S-Z661, 5K0S-Z668, 4K0S-S711, 5K0S-306C, 5K0S-159D, 5K0S-881D, 6K0S-491J, 6K0S-501F, 6K0S-435N, 7K0S108256, 6K0S-746N, 5K0S-311C, 6K0S-508F, 6K0S-016M, 5K0S-305C, 6K0S-532F, 6K0S-318H, 6K0S-722R, 5K0S-Y002, 6K0S-481K, 6K0S-488K, 6K0S-669L, 4K0S-Q643, 5K0S-Y003, 4K0S-M704, 4K0S-M707, 4K0S-N849, 4K0S-P288, 4K0S-Q641, 4K0S-Q689, 4K0S-Q690, 4K0S-Q691, 4K0S-R109, 4K0S-R113, 4K0S-R134, 4K0S-R137, 4K0S-S704, 5K0S-T897, 5K0S-T898, 5K0S-V200, 5K0S-V201, 5K0S-X989, 5K0S-883D, 6K0S-468G, 6K0S-847G, 6K0S-848G, 6K0S-092L, 6K0S-322L, 6K0S-673L, 6K0S-992P, 6K0S-998P, 4K0S-M706, 4K0S-R083, 4K0S-S712, 4K0S-S722, 5K0S-V191, 5K0S-V204, 5K0S-X987, 5K0S-X990, 5K0S-Z667, 5K0S-466B, 6K0S-219E, 6K0S-482J, 6K0S-835N, 6K0S-778R, 7K0S100621, 7K0S102665, 7K0S103781, 4K0S-S715, 5K0S-V202, 5K0S-885D, 4K0S-N844, 4K0S-P292, 4K0S-S706, 5K0S-T887, 5K0S-T892, 5K0S-Z664, 5K0S-184C, 5K0S-Z654, 5K0S-Z660, 6K0S-437N, 6K0S-834N, 6K0S-015R, 5K0S-160D, 6K0S-815K, 6K0S-022M, 6K0S-757N, 6K0S-504F, 7K0S100578, 6K0S-482K, 6K0S-485K, 6K0S-981P, 6K0S-007Q, 6K0S-805K, 6K0S-777R, 7K0S102982, 7K0S100940, 5K0S-Z666, 6K0S-484J, 6K0S-325L, 6K0S-486J, 6K0S-010M, 7K0S100714, 6K0S-006M, 6K0S-060N, 6K0S-432N, 6K0S-787R, 6K0S-952Q, 7K0S100579, 7K0S107999, 6K0S-017R, 7K0S102656, 6K0S-750N, 5K0S-882D, 6K0S-008M, 6K0S-026M, 6K0S-945Q, 6K0S-010R, 6K0S-671L, 6K0S-018M, 5K0S-880D, 6K0S-216E, 6K0S-503F, 6K0S-438N, 7K0S109372, 6K0S-220E, 6K0S-515F, 6K0S-510F, 6K0S-507F, 6K0S-484G, 6K0S-331H, 6K0S-326H, 6K0S-323H, 6K0S-483J, 6K0S-820K, 6K0S-610L, 6K0S-756N, 7K0S105078, 5K0S-879D, 6K0S-471G, 6K0S-477G, 6K0S-845G, 6K0S-672L, 6K0S-511F, 6K0S-336H, 6K0S-322H, 6K0S-431N, 6K0S-051M, 7K0S100618, 6K0S-478K, 6K0S-050M, 6K0S-976P, 6K0S-807K, 6K0S-024M, 7K0S101630, 7K0S106399, 7K0S107631, 7K0S107628, 7K0S108079, 7K0S108483, 7K0S110137, 7K0S106378, 7K0S109370, 5K0S-Z658, 4K0S-S720, 4K0S-S710, 4K0S-P296, 6K0S-816K, 7K0S103840, 7K0S103896, 7K0S107752, 7K0S107922, 7K0S103596, 7K0S108258, 6K0S-334H, 6K0S-338H, 6K0S-339H, 6K0S-479G, 6K0S-846G, 6K0S-851G, 6K0S-852G, 6K0S-982G, 5K0S-V196, 5K0S-463B, 7K0S110484, 6K0S-025M, 7K0S110416, 7K0S110417, 7K0S110418, 7K0S107748, 5K0S-Y007, 5K0S-Z663, 5K0S-Z656, 5K0S-X986, 5K0S-164D, 6K0S-718R, 6K0S-776R, 6K0S-715R, 6K0S-717R, 6K0S-727R, 6K0S-729R, 6K0S-732R, 6K0S-783R, 7K0S103782, 7K0S108482, 6K0S-808K, 7K0S102985, 7K0S108257, 7K0S105021, 7K0S101634, 6K0S-014Q, 5K0S-T888, 5K0S-T889, 5K0S-163D, 5K0S-167D, 6K0S-993P, 7K0S110119, 7K0S110136, 5K0S-354D, 6K0S-027M, 6K0S-056N, 6K0S-057N, 7K0S108373, 7K0S103897, 5K0S-321C, 4K0S-N160, 6K0S-319H, 5K0S-451B, 7K0S103050, 7K0S109903, 7K0S109904, 7K0S110431, 6K0S-490K, 7K0S100577, 7K0S100716, 7K0S105993, 7K0S108486, 5K0S-Z659, 6K0S-472J, 7K0S109397, 6K0S-317L, 6K0S-320L, 7K0S106053, 6K0S-491K, 7K0S106458, 7K0S107751, 4K0S-N158, 7K0S107630, 7K0S103843, 7K0S108328, 7K0S108376, 7K0S108485, 7K0S100718, 5K0S-T899, 5K0S-166D, 5K0S-355D, 7K0S106397, 7K0S108330, 5K0S-T881, 6K0S-017M, 7K0S106400, 7K0S106456, 7K0S106467, 4K0S-L720, 4K0S-L721, 6K0S-475K, 6K0S-477K, 6K0S-011M, 6K0S-023M, 6K0S-053M, 7K0S106460, 6K0S-472K, 7K0S103898, 7K0S103529, 7K0S109466, 4K0S-R110, 6K0S-512F, 6K0S-469J, 7K0S109462, 5K0S-V193, 6K0S-986P, 7K0S100936, 7K0S107745, 7K0S107996, 7K0S107997, 4K0S-S721, 4K0S-Q636, 6K0S-487J, 6K0S-975P, 6K0S-987P, 6K0S-9

Risk classification

Class II

Area (FDA)

device

Country

United States