FDA recall Z-2090-2021

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

Product

050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap is equivalent to that for the Fresenius Stay Safe Cap and is as follows: Indications for Use Fresenius Sterile Stay Safe¿ Cap is intended to be used for closure of the stay safe peritoneal dialysis connectology system

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-2090-2021