Device recall
Z-1311-2019: MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System…
FDA device recall · Class I · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-1311-2019 |
|---|---|
| Recall event | 82659 |
| Product | MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid space to… |
| Product code | JXG |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 27, 2021 |
| 510(k) numbers | K022554, K062599 |
| FEI number | 3003418325 |
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