Home / Recalls / Medical Devices
Natus Manufacturing Limited recalls Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (C
Recalled March 3, 2021 · FDA recall Z-1143-2021 · Natus Manufacturing
Hazard
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins. · FDA Class II
Units
7 units
Sold at
US Nationwide distribution in the state of NY.
Description
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
Product
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.
Manufacturer(s)
Natus Manufacturing Limited
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →