Fresenius Medical Care Holdings, Inc.: RTLR190395: 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: 6 units Lot/code info: Model Number: RTLR190395 (Refurbished Rental units); UDI/DI: 00840861100958; Serial Numbers: 6K0S-514F, 6K0S-472G, 6K0S-052M, 6K0S-058N, 5K0S-322B, 5K0S-U131.

UPC codes

00840861100958

Source

Official record: FDA (Device enforcement) ↗

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