Fresenius Medical Care Holdings, Inc.: 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

Hazard

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

Details from the source

Reason for recall: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves. Distribution: US Nationwide distribution. Quantity: 12,292 units Lot/code info: Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191126, UDI/DI: 00840861102099; Serial Numbers: 3T0S270687, 3T0S270700, 3T0S274007, 3T0S274009, 3T0S274011, 3T0S274012, 3T0S274016, 3T0S274057, 3T0S274859, 3T0S274920, 3T0S274922, 3T0S274923, 3T0S274938, 3T0S274957, 3T0S274969, 3T0S274970, 3T0S274980, 3T0S274985, 3T0S274996, 3T0S274997, 3T0S275004, 3T0S275009, 3T0S275011, 1T0S262226, 1T0S262249, 1T0S262254, 1T0S262257, 1T0S262265, 1T0S262266, 1T0S262267, 1T0S262268, 1T0S262269, 1T0S262272, 1T0S262273, 1T0S262274, 1T0S262275, 1T0S262276, 1T0S262278, 1T0S262279, 1T0S262280, 1T0S262282, 1T0S262283, 1T0S262284, 1T0S262285, 1T0S262286, 1T0S262289, 1T0S262293, 1T0S262294, 1T0S262296, 1T0S262297, 1T0S262299, 1T0S262300, 1T0S262305, 1T0S262313, 1T0S262315, 1T0S262319, 1T0S262321, 4T0S275623, 4T0S275627, 4T0S275628, 4T0S275629, 4T0S275639, 4T0S275649, 4T0S275654, 4T0S275662, 4T0S275664, 4T0S275666, 4T0S275677, 4T0S275682, 4T0S275685, 4T0S275688, 4T0S275692, 4T0S275703, 4T0S275729, 4T0S275738, 4T0S275742, 4T0S275745, 4T0S275760, 4T0S275768, 4T0S275769, 4T0S275778, 4T0S275787, 4T0S275800, 4T0S275804, 4T0S276804, 4T0S276814, 4T0S276818, 4T0S276829, 4T0S276833, 4T0S276838, 4T0S276858, 4T0S276867, 4T0S276870, 3T0S269793, 3T0S269826, 3T0S269827, 3T0S269828, 3T0S269836, 3T0S269838, 3T0S269841, 3T0S269842, 3T0S269954, 3T0S269955, 3T0S269956, 3T0S269957, 3T0S269959, 3T0S269960, 3T0S269961, 3T0S269963, 3T0S269964, 3T0S269965, 3T0S269966, 3T0S2

UPC codes

00840861102099

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.