Ref: NT821731C — Class II medical device recall Z-1143-2021
Terminated recall by Natus Manufacturing Limited, reported 2021-03-03, distributed nationwide. The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal flu
| Recall number | Z-1143-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Natus Manufacturing Limited, Galway, N/A, Ireland |
| Recall initiated | 2021-01-12 |
| Classified | 2021-02-22 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2022-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 7 units |
| Reason classes | sterility |
| Lot numbers | 118000422298 |
| Model numbers | NT821731C |
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 for recall
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1143-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.