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U.S. Department of Health and Human Services

Class 2 Device Recall Natus EDS3 CSF External Drainage System

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  Class 2 Device Recall Natus EDS3 CSF External Drainage System see related information
Date Initiated by Firm January 12, 2021
Create Date February 22, 2021
Recall Status1 Open3, Classified
Recall Number Z-1143-2021
Recall Event ID 87175
510(K)Number K162437  
Product Classification Shunt, central nervous system and components - Product Code JXG
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.
Code Information Lot # 118000422298
Recalling Firm/
Manufacturer
Natus Manufacturing Limited
Ida Business Park
Glenbrack Road
Galway Ireland
Manufacturer Reason
for Recall
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
FDA Determined
Cause 2
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: FCA@Natus.com
Quantity in Commerce 7 units
Distribution US Nationwide distribution in the state of NY.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JXG and Original Applicant = Codman & Shurtleff, Inc.
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