Z-1143-2021Class II

Ref: NT821731C, Natus EDS 3 CSF External Drainage System -

Name: Z-1143-2021 Ref: NT821731C, Natus EDS 3 CSF External Drainage System -
Creator: Natus Manufacturing Limited
Published: 2021-01-12
License: https://open.fda.gov/license/

Natus Manufacturing Limited / initiated 2021-01-12 / Terminated / root cause: sterility

FDA source

Natus Manufacturing Limited began a recall of Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the... on 2021-01-12. FDA classified it as Class II and gives the reason as "The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1143-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-12
Posted: 2021-02-22
Terminated: 2022-11-08
Recalling firm: Natus Manufacturing Limited
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.
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
Root cause tag: sterility
FDA root cause: Release of Material/Component prior to receiving test results
Action: On January 12, 2021, Natus sent an "Urgent Field Safety Notice - Recall" notification to all affected consignees via US Mail. In addition to informing consignees about the recall, the notification asked consignees to take the following actions: 1. Please return these affected items at your earliest convenience to the following address: 3150 Pleasant View Road, Middleton, WI 53562 USA 2. Replacement product is available. The Technical Service department will be in contact in relation to the provision of the replacement product. 3. Please complete and return the customer reply form to Natus at the following Email address: [email protected]
Quantity in commerce: 7 units
Distribution: US Nationwide distribution in the state of NY.
Product codes and lots: Lot # 118000422298

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1143-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1143-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-22

Product code JXG

K162437Class IICodman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. / cleared 2016-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)