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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Detail

Product Description 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
Recall Number Z-1468-2014
Classification Class II
Code Info All serial numbers
Product Distributed Qty 9,445 units
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.

Event Detail

Event Id 67793
Product Type Devices
Status Ongoing
Recalling Firm Codman & Shurtleff, Inc.
City Raynham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.