Natus Manufacturing Limited recalls Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (C…

Recall date

January 12, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1143-2021

FDA classification

Class II

Brand / firm

Natus Manufacturing Limited

Sold / distributed

US Nationwide distribution in the state of NY.

Why it was recalled

The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 not indicated.