Date Initiated by Firm | January 12, 2021 |
Create Date | February 22, 2021 |
Recall Status1 |
Terminated 3 on November 08, 2022 |
Recall Number | Z-1143-2021 |
Recall Event ID |
87175 |
510(K)Number | K162437 |
Product Classification |
Shunt, central nervous system and components - Product Code JXG
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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
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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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JXG
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