Fresenius Medical Care Holdings, Inc.: 2008T BlueStar Hemodialysis Machine, Model 191130 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: 11,371 units Lot/code info: Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191130, UDI/DI: 00840861102112; Serial Numbers: 2T0S265095, 2T0S265131, 2T0S266383, 2T0S266406, 2T0S266459, 0T0S251328, 0T0S251333, 0T0S251334, 0T0S251335, 0T0S251337, 0T0S251338, 0T0S251343, 0T0S251345, 0T0S251347, 0T0S251348, 0T0S251349, 0T0S251354, 0T0S251363, 0T0S251365, 0T0S251368, 0T0S251370, 0T0S251375, 0T0S251385, 0T0S251401, 0T0S251413, 0T0S251419, 0T0S254338, 0T0S254385, 0T0S252442, 0T0S252451, 0T0S252453, 2T0S268393, 3T0S273665, 0T0S254884, 0T0S254888, 0T0S254893, 4T0S277762, 4T0S277765, 4T0S277775, 4T0S277785, 4T0S277787, 4T0S277791, 4T0S277793, 4T0S277795, 4T0S277800, 4T0S277801, 4T0S277802, 4T0S277806, 4T0S277807, 4T0S277808, 4T0S277812, 4T0S277817, 4T0S277818, 4T0S277821, 4T0S277822, 4T0S277831, 4T0S277860, 4T0S277869, 3T0S270989, 3T0S270996, 3T0S271096, 3T0S271365, 3T0S271366, 3T0S271368, 3T0S271370, 3T0S271372, 3T0S271374, 3T0S271375, 3T0S271386, 3T0S271388, 3T0S271391, 3T0S271405, 3T0S271408, 3T0S271412, 3T0S271423, 3T0S271461, 3T0S271473, 3T0S271474, 3T0S271476, 3T0S271489, 3T0S271490, 3T0S271513, 3T0S271525, 3T0S271533, 1T0S257450, 1T0S257451, 1T0S257452, 1T0S257453, 1T0S257456, 1T0S257458, 1T0S257459, 1T0S257460, 1T0S257461, 1T0S257462, 1T0S257463, 1T0S257464, 1T0S257476, 1T0S257484, 1T0S257493, 1T0S257533, 1T0S257558, 1T0S257562, 1T0S257570, 1T0S257579, 1T0S257583, 1T0S257618, 1T0S257630, 1T0S257648, 1T0S257654, 0T0S251455, 0T0S251464, 0T0S251474, 0T0S2

UPC codes

00840861102112

Source

Official record: FDA (Device enforcement) ↗

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