FDA-Device2012-07-18Class II
Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.
Integra LifeSciences Corp
Hazard
The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. The incorrect label reads: "Model: 12 mm-Medium Pressure" instead of "Model: 16 mm-Low Pressure".
Sold states
International Only Distribution, including the countries of Thailand and Japan.
Affected count
39 units
Manufactured in
105 Morgan Ln, Plainsboro, NJ, United States
Products
Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1984-2012Don't want to check this manually?
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