Class 2 Device Recall CereLink ICP Monitor

• Date Initiated by Firm: September 12, 2019
• Create Date: October 12, 2019
• Recall Status: Open, Classified
• Recall Number: Z-0124-2020
• Recall Event ID: 83831
• 510(K)Number: K183406
• Product Classification: Device, monitoring, intracranial pressure - Product Code GWM
• Product: Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
• Code Information: All systems
• FEI Number: 3003418325
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: Dr. Patricia Kihn; 717-309-3966
• Manufacturer Reason for Recall: There is a potential for a progressive decline in observed ICP readings of the monitor during use.
• FDA Determined Cause: Under Investigation by firm
• Action: On 9/12/19, the customers were notified by a visit from the Sales Representative who delivered a notification letter at that time. The letter, URGENT: VOLUNTARY MEDICAL DEVICE RECALL, dated 9/12/19, included the following instructions: 1. If you have a CereLink ICP monitor, Model #826820, discontinue using the product as soon as clinically possible and remove the product from service. 2. Your sales representative will facilitate the return of your monitor. 3. Complete the information on the Acknowledgement Form attached to this letter and either provide it to your sales representative or email or fax as indicated on the form. Keep a copy of the form for your records. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM  8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com Outside USA: 781-565-1401
• Quantity in Commerce: 189
• Distribution: The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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