Device recall
Z-1310-2019: MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr…
FDA device recall · Class I · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-1310-2019 |
|---|---|
| Recall event | 82659 |
| Product | MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Valve w MoniTorr 10110 10-110 CSF Drainage System used with Pole Mount System MoniTorr 10140 10-140 CSF Drainage System w/Vinyl Measuring Strip MoniTorr 10150… |
| Product code | JXG |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 27, 2021 |
| 510(k) numbers | K022554, K062599, K920156 |
| 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