FDAJanuary 12, 2021device
Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
What to do
FDA enforcement status: Terminated
Brands named
natus manufacturingnatus
UPCs
118000422298
Recall history
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