CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In...
FDA Recall #Z-1468-2014 — Class II — December 13, 2013
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
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.
Recalling Firm
Codman & Shurtleff, Inc. — Raynham, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
9,445 units
Distribution
Nationwide Distribution.
Code Information
All serial numbers
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated