FDA recall Z-1143-2021

Natus Manufacturing Limited · Class II · device

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.

Reason for recall

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

Distribution

US Nationwide distribution in the state of NY.

Key facts

Status
Terminated
Initiation date
2021-01-12
Report date
2021-03-03
Termination date
2022-11-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Galway, N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1143-2021