Fresenius Medical Care Holdings, Inc.: 2008T BlueStar Hemodialysis Machine, Model 191124 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: 931 units Lot/code info: Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191124, UDI/DI: 00840861102082; Serial Numbers: 0T0S252551, 0T0S252801, 0T0S252806, 1T0S255908, 1T0S256180, 0T0S251792, 0T0S251809, 0T0S251811, 0T0S252810, 0T0S251585, 0T0S251883, 0T0S251899, 1T0S256179, 1T0S256183, 1T0S256184, 1T0S256185, 1T0S256188, 1T0S256190, 1T0S256192, 1T0S256193, 1T0S256197, 1T0S256213, 1T0S256219, 1T0S256220, 1T0S256233, 1T0S256249, 1T0S256255, 1T0S256256, 1T0S256262, 1T0S256278, 1T0S256281, 1T0S256282, 1T0S256286, 2T0S264834, 2T0S264839, 2T0S264852, 2T0S264856, 3T0S272211, 3T0S274176, 3T0S274177, 3T0S274178, 3T0S274183, 3T0S274187, 3T0S274189, 3T0S274190, 3T0S274192, 3T0S274194, 3T0S274195, 3T0S274197, 3T0S274202, 3T0S274204, 3T0S274205, 3T0S274207, 3T0S274209, 1T0S255921, 1T0S255924, 1T0S255936, 1T0S255937, 0T0S252151, 0T0S252175, 0T0S252538, 0T0S252542, 0T0S252554, 0T0S252843, 1T0S255902, 1T0S255904, 1T0S255913, 1T0S255914, 1T0S255915, 1T0S255928, 1T0S255929, 1T0S255930, 1T0S255933, 0T0S251304, 0T0S251902, 0T0S251905, 0T0S251574, 0T0S251616, 0T0S251844, 0T0S251846, 0T0S251856, 0T0S252102, 0T0S252107, 0T0S252124, 0T0S252128, 0T0S252132, 0T0S252143, 0T0S252150, 0T0S252529, 0T0S251885, 0T0S251916, 0T0S251920, 0T0S251929, 0T0S252091, 0T0S252097, 0T0S252100, 0T0S252121, 0T0S252131, 0T0S252136, 0T0S252139, 0T0S252161, 0T0S252163, 1T0S256205, 1T0S256222, 1T0S256225, 1T0S256229, 1T0S256245, 1T0S256266, 1T0S255987, 1T0S255993, 1T0S255998, 1T0S255999, 1T0S2

UPC codes

00840861102082

Source

Official record: FDA (Device enforcement) ↗

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