Device recall
Z-1143-2021: Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage…
FDA device recall · Class II · Natus Manufacturing Limited
Key facts
| Recall number (Z-number) | Z-1143-2021 |
|---|---|
| Recall event | 87175 |
| 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… |
| Product code | JXG |
| Recalling firm | Natus Manufacturing Limited |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 8, 2022 |
| 510(k) numbers | K162437 |
| FEI number | 3005581270 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database