Fresenius Medical Care Holdings, Inc.: 190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, 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: Domestic: Nationwide Distribution. International: Canada. Quantity: 372 units Lot/code info: Model Number: 190904; UDI/DI: 00840861100965; Serial Numbers: 5K0S194173, 7K0S300085, 4K0S190310, 4K0S190311, 4K0S190312, 4K0S190314, 4K0S190315, 4K0S190318, 4K0S190321, 4K0S192510, 4K0S192511, 4K0S192812, 4K0S192813, 4K0S192814, 4K0S192815, 4K0S192816, 4K0S192817, 4K0S192818, 4K0S192819, 4K0S192820, 4K0S192821, 4K0S192822, 4K0S192823, 4K0S192824, 4K0S192825, 4K0S192826, 4K0S192827, 4K0S192828, 4K0S192829, 4K0S192830, 4K0S192831, 4K0S192832, 5K0S194166, 5K0S194176, 6K0S172023, 7K0S300011, 7K0S300034, 6K0S172010, 7K0S300092, 7K0S300105, 7K0S300067, 7K0S300074, 7K0S300069, 6K0S172008, 5K0S194162, 6K0S163684, 6K0S172021, 7K0S300019, 7K0S300062, 7K0S300016, 7K0S300027, 6K0S171203, 6K0S169446, 6K0S159427, 6K0S167051, 5K0S193166, 5K0S194156, 6K0S167044, 6K0S167045, 6K0S167049, 6K0S159417, 6K0S165409, 5K0S194145, 6K0S169433, 5K0S193324, 5K0S193676, 6K0S165407, 5K0S193147, 5K0S193677, 6K0S171200, 6K0S167035, 5K0S193312, 6K0S159423, 6K0S159430, 6K0S165412, 6K0S169448, 6K0S172019, 7K0S300009, 7K0S300012, 7K0S300006, 7K0S300007, 7K0S300013, 7K0S300025, 6K0S169442, 5K0S193318, 6K0S162829, 6K0S163670, 6K0S171205, 5K0S194159, 5K0S194169, 5K0S194167, 5K0S194172, 6K0S172022, 5K0S194178, 5K0S193319, 7K0S300040, 6K0S172001, 7K0S300044, 7K0S300060, 5K0S193161, 5K0S193162, 5K0S193165, 5K0S193167, 5K0S193146, 5K0S193151, 5K0S193159, 5K0S193313, 5K0S193332, 5K0S193314, 5K0S193317, 5K0S193326, 5K0S193678, 6K0S162830, 6K0S162834, 6K0S162837, 6K0S162842, 6K0S162844, 6K0S162840, 6K0S162845, 7K0S300032

UPC codes

00840861100965

Source

Official record: FDA (Device enforcement) ↗

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