FDA recall Z-2085-2021

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

Product

026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting

Reason for recall

Exposed to freezing temperatures due to refrigerated truck malfunctions

Distribution

US Distribution to: TX only

Key facts

Status
Terminated
Initiation date
2021-04-28
Report date
2021-07-28
Termination date
2022-08-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2085-2021