Natus Manufacturing Limited Recall 87175
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.
Natus Manufacturing Limited Recall 87175 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1143-2021 |
| Event ID | 87175 |
| Event 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 Type | Devices |
| Distribution | US Nationwide distribution in the state of NY. |
| Quantity | 7 units |
| Recall Reason | The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins. |
| Device Classification | 20210303 |
| Device Code Info | Lot # 118000422298 |
| Center Classification Date | 20210222 |
| Recall Initiation Date | 20210112 |
| Recalling Firm | Natus Manufacturing Limited |
| Initial Notification | Letter |
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