Class 2 Device Recall Integral Lumbar Drainage Set

• Date Initiated by Firm: August 23, 2016
• Create Date: September 30, 2016
• Recall Status: Terminated on March 29, 2017
• Recall Number: Z-2907-2016
• Recall Event ID: 75065
• 510(K)Number: K924600
• Product Classification: Shunt, central nervous system and components - Product Code JXG
• Product: Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary packaged in to Tyvek pouch. Internal drainage set is primary packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, One (1) sealed package of lumbar catheter and Internal drainage set are finally packed in a cardboard box. Intended for CSF external drainage
• Code Information: Catalog Number 910420, Lot #0195878 with expiry 10/2018
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: Dr. Patricia Kihn; 717-840-3431
• Manufacturer Reason for Recall: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
• FDA Determined Cause: Process control
• Action: Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
• Quantity in Commerce: 18
• Distribution: Nationwide Distribution to KS only
• 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 = JXG