Z-1097-04

Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains...

Name: Z-1097-04 Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains...
Creator: Integra Life Sciences Corp.
Published: 2003-03-19
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2003-03-19 / Terminated / root cause: labeling and UDI

FDA source

Integra Life Sciences Corp. began a recall of Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter... on 2003-03-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1097-04
Status: Terminated
Initiated: 2003-03-19
Posted: 2004-07-20
Terminated: 2004-08-05
Recalling firm: Integra Pain Management
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.
Product code: HCA Catheter, Ventricular
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 6 kits
Distribution: The product was shipped to one hospital in NY.
Product codes and lots: Kit No 31176, Lot 03419

Product code HCA

K961113Class IICns Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC / cleared 1996-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)