FDA-Device2025-01-29Class II
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Integra LifeSciences Corp.
Hazard
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Sold states
US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.
Affected count
132 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0977-2025Don't want to check this manually?
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