FDA Device recall Z-1143-2021
Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebra…
- FDA Device
- Class II
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class II recall of Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebra… by Natus Manufacturing, citing the external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1143-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-12 |
| Published | 2021-03-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Natus Manufacturing |
| Distribution | US |
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.
Reason
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
Identifiers
| code_info | Lot # 118000422298 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1143-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.