FDA recall Z-2344-2024

Fresenius Medical Care Holdings, Inc. · Class II · device

Product

RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

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.

Key facts

Status: Ongoing
Initiation date: 2024-06-03
Report date: 2024-07-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2344-2024