FDA recall Z-0619-2024

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

Product

Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

Reason for recall

Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.

Distribution

US Nationwide distribution in the states of AL, CA, FL, IL, IN, LA, MI, MO, MT, NC, NJ, NV, OH, OK, OR, PA, SC, TN, TX, VA.

Key facts

Status
Ongoing
Initiation date
2023-10-24
Report date
2024-01-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0619-2024