Device recall
Z-2588-2010: Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-2588-2010 |
|---|---|
| Recall event | 55708 |
| Product | Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; Sterile, Rx only. Manufactured by Integra NeuroSciences Implants S.A., Sophia Antipolis Cedex, France; distributed by Integra NeuroSciences, 311 Enterprise Drive, Plainsboro, NJ 08538; This product is… |
| Product code | GCY |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 27, 2012 |
| FEI number | 3003418325 |
At a glance
- None 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