FDA Medical Device Recalls (openFDA)
Integra Life Sciences Corp.: Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one INS-HITH Cranial Access Kit, one Sodium Chloride 10 ml, and one Suture 2-0 silk.
- Recall number
- Z-1097-04
- Recalling firm
- Integra Life Sciences Corp.
- Product
- Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one INS-HITH Cranial Access Kit, one Sodium Chloride 10 ml, and one Suture 2-0 silk.
- Status
- Terminated
- Initiated
- 2003-03-19
- Posted
- 2004-07-20
- Terminated
- 2004-08-05
- Reason
- 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.
- Root cause
- Other
- Action
- The recalling firm telephoned the customer on 3/19/03. The recalling firm followed up with a recall letter on 3/24/03.
- Quantity
- 6 kits
- Distribution
- The product was shipped to one hospital in NY.
- Lot, serial or model codes
- Kit No 31176, Lot 03419
- 510(k) numbers
- ["K961113"]
- PMA numbers
- not on file
- Product code
- HCA
- Firm FEI
- 1000125384
- Firm city
- Exton
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28