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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description 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.
Recall Number Z-1984-2012
Classification Class II
Code Info 1115647, 1115939, 1120413
Product Distributed Qty 39 units
Reason For Recall 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".

Event Detail

Event Id 62138
Product Type Devices
Status Completed
Recalling Firm Integra LifeSciences Corp
City Plainsboro
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-04
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern International Only Distribution, including the countries of Thailand and Japan.