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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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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
Distribution Pattern International Only Distribution, including the countries of Thailand and Japan.

Product Detail

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