Device recall
Z-2908-2016: Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-2908-2016 |
|---|---|
| Recall event | 75065 |
| Product | Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF |
| Product code | JXG |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 29, 2017 |
| 510(k) numbers | K855058 |
| 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