Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermet
FDA device recall Z-1097-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Integra Life Sciences Corp.
- Reason for recall
- The outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottle of 1% Xylocaine was included in the Custom Kit.
- Action taken
- The recalling firm telephoned the customer on 3/19/03. The recalling firm followed up with a recall letter on 3/24/03.
- Root cause
- Other
- Status
- Terminated
- Product code
- HCA
- Quantity affected
- 6 kits
- Distribution
- The product was shipped to one hospital in NY.
- Date initiated
- 2003-03-19
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-05
- Location
- Exton, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CNS INTERCHANGEABLE BIT CRANIAL DRILL (K961113) | Clinical Neuro Systems, LLC | 1996-06-05 |