Device recall
Z-0750-2012: Cranial Access Kit Ref INSHITHNR Integra NeuroSciences Plainsboro, NJ 08536…
FDA device recall · Class II · Integra LifeSciences Corp. d.b.a. Integra Pain Management
Key facts
| Recall number (Z-number) | Z-0750-2012 |
|---|---|
| Recall event | 60798 |
| Product | Cranial Access Kit Ref INSHITHNR Integra NeuroSciences Plainsboro, NJ 08536 Sterile and non-sterile contents, Single use device, Do not resterilize, Prep and Closure Kit Contents Sterile & Non-Sterile, (1) Lidocaine 1.5% w/ Epinephrine (30 ml VIAL). Sterile EO, Contents 5 units. Product Usage: The… |
| Product code | HBG |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2012 |
| 510(k) numbers | K961113 |
| FEI number | 1000138491 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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