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U.S. Department of Health and Human Services

Class 2 Device Recall CODMAN CERTAS Programmable Valves

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  Class 2 Device Recall CODMAN CERTAS Programmable Valves see related information
Date Initiated by Firm December 13, 2013
Date Posted April 17, 2014
Recall Status1 Terminated 3 on April 21, 2016
Recall Number Z-1468-2014
Recall Event ID 67793
510(K)Number K112156  K113526  
Product Classification Shunt, central nervous system and components - Product Code JXG
Product CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows:
82-8800 In Line Valve Only
82-8801 In Line Valve with Catheter and Accessories
82-8802 In Line Valve with Unitized Catheter and Accessories
82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories
82-8804 In Line Valve only with SIPHONGUARD Device
82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories
82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories
82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories

82-8850 Certas Therapeutic Management System
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information Contact SAME
508-880-8000
Manufacturer Reason
for Recall		 Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.
FDA Determined
Cause 2		 Process control
Action Codman Neuro issued notification packages dated 12/13/13 to Domestic Hospitals and international accounts. Specific letters and associated inclusion of the additional aids, include A) a valve setting verification guide with instructions for use with x-ray images, and B) a plastic valve cut out overlay). A response reply form was included to be completed and returned to confirm effectiveness of the notification.
Quantity in Commerce 9,445 units
Distribution Nationwide Distribution.
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 and Original Applicant = MEDOS INTERNATIONAL SARL
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