FDA recall Z-1303-2022

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

Product

Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

Reason for recall

Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

Distribution

US Nationwide distribution in the state of Pennsylvania.

Key facts

Status: Terminated
Initiation date: 2022-05-04
Report date: 2022-07-06
Termination date: 2024-05-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1303-2022