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Codman & Shurtleff, Inc. recalls Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803
Recalled February 5, 2014 · FDA recall Z-0860-2014 · Codman & Shurtleff
Hazard
Codman Certas Programmable Valves used for hydrocephalus may not operate properly · FDA Class II
Units
431 units
Sold at
Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
Description
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Product
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Manufacturer(s)
Codman & Shurtleff, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →