Drug recall
Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal…
FDA recall event 87175 · Class II · Natus Manufacturing Limited
Key facts
| Event ID | 87175 |
|---|---|
| Recall numbers | Z-1143-2021 |
| Recalling firm | Natus Manufacturing Limited |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins. |
| Initiation date | Jan 12, 2021 |
| Report date | Mar 3, 2021 |
| Termination date | Nov 8, 2022 |
| City | Galway |
| Country | Ireland |
| FEI number | 3005581270 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: