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Integra LifeSciences Corp recalls Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Devic
Recalled July 18, 2012 · FDA recall Z-1984-2012 · Integra LifeSciences
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". · FDA Class II
Units
39 units
Sold at
International Only Distribution, including the countries of Thailand and Japan.
Description
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".
Product
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.
Manufacturer(s)
Integra LifeSciences Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →