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U.S. Department of Health and Human Services

Class 1 Device Recall Codman CereLink ICP Extension Cable

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  Class 1 Device Recall Codman CereLink ICP Extension Cable see related information
Date Initiated by Firm October 05, 2023
Date Posted December 14, 2023
Recall Status1 Open3, Classified
Recall Number Z-0548-2024
Recall Event ID 93084
510(K)Number K232890  K210993  
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
Product CereLink ICP Extension Cable (Extension Cable), Model No. 826845

Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part of the same SKU.
Code Information UDI-DI 10381780520665 All lots distributed
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information Contact Lacey Gigante
609-212-9004
Manufacturer Reason
for Recall		 Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of range readings" issue.
FDA Determined
Cause 2		 Device Design
Action On October 5, 2023, the firm issued an updated letter, intended to replace the notification sent on June 22, 2022 for the out-of-range readings issue (RES 90457). As an output of the root cause and failure investigation, the design of the extension cable is being modified to incorporate a solution to address the "out of range readings" issue. The firm instructed customers to return all existing CereLink ICP Extension Cables in their inventory. This includes all CereLink ICP Extension Cables included with the monitor AND all CereLink ICP Extension Cables provided separately. Customers should check their inventory and quarantine any affected product. Once the firm receives the customer's response form, the firm will provide instructions to return the product. Customers with questions about this recall should contact their Account Manager.
Quantity in Commerce 4941
Distribution US distribution nationwide to the following states: AL AR AZ CA CO CT DC DE FL GA IA KY LA MA ME MN ND NE NH NJ NY OK PA RI TN TX UT VA WI WV OUS distribution to Australia/New Zealand, Canada, and Europe/Middle East/Africa.
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 and Original Applicant = Integra LifeSciences Production Corporation
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