Recall Z-1143-2021 ยท JXG Shunt, Central Nervous System And Components
Natus Manufacturing Limited
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.
| Date | Jan 12, 2021 |
| Status | Terminated |
| Reason | The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins. |
| 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 |
| Quantity | 7 units |
| Distribution | US Nationwide distribution in the state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162437 | Codman EDS3 CSF External Drainage System Codman & Shurtleff, Inc., Oct 28, 2016 |