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.
FDA Recall Z-1984-2012 · Posted 2012-07-10
Recalling FirmIntegra LifeSciences Corp
Recall StatusTerminated
Product CodeJXG
Date Initiated2012-04-04
Date Terminated2012-08-02
Product Quantity39 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".
Firm Action
The firm initiated a voluntary recall by notifying the two consignees initially via email and then with an "URGENT: MEDICAL DEVICE RECALL" dated April 5th or 9th, 2012. The letter informed them of the labeling error and provided instructions regarding affected product. The International Customer Service number was provided 609-936-5400.
Root Cause
Labeling Change Control
Distribution Pattern
International Only Distribution, including the countries of Thailand and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.