FDA-Device2021-07-28Class II
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
Fresenius Medical Care Holdings, Inc.
Hazard
Exposed to freezing temperatures due to refrigerated truck malfunctions
Sold states
US Distribution to: TX only
Affected count
39 cases
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2090-2021Don't want to check this manually?
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