Fresenius Medical Care Holdings, Inc.: RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - 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: 17 Units Lot/code info: Model Number: RTL190395 (Rental Units); UDI/DI: 00840861100958; Serial Numbers: 4K0S-R138, 5K0S-Z652, 5K0S-462B, 5K0S-Z669, 6K0S-505F, 6K0S-513F, 6K0S-850G, 6K0S-480J, 6K0S-467K, 6K0S-995P, 7K0S103784, 6K0S-009M, 7K0S110463, 7K0S110427, 7K0S110771, 6K0S-725R, 6K0S-324L,

UPC codes

00840861100958

Source

Official record: FDA (Device enforcement) ↗

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