FDA recall Z-1867-2024

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

Product

2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, 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

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-04-17
Report date: 2024-05-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1867-2024