Natus Manufacturing Limited: Medical Device Recall in 2021 - (Recall #: Z-1143-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 12, 2021

Date Posted: March 3, 2021

Recall Number: Z-1143-2021

Event ID: 87175

Reason for Recall:

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

Status: Terminated

Product Quantity: 7 units

Code Information:

Lot # 118000422298

Distribution Pattern:

US Nationwide distribution in the state of NY.

Voluntary or Mandated:

Voluntary: Firm initiated