Class 2 Device Recall Cranial Access Kit

• Date Initiated by Firm: March 19, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on August 05, 2004
• Recall Number: Z-1097-04
• Recall Event ID: 25912
• 510(K)Number: K961113
• Product Classification: Catheter, Ventricular - Product Code HCA
• 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.
• Code Information: Kit No 31176, Lot 03419
• FEI Number: 1000125384
• Recalling Firm/ Manufacturer: Integra Life Sciences Corp.; 309 Commerce Dr; Exton PA 19341
• For Additional Information Contact: Donna R. Wallace; 609-936-2397
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HCA