—#109901

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.

FDA product code: JXG — Shunt, Central Nervous System And Components
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K760501
Affected lot / code info: 1115647, 1115939, 1120413

Why it was recalled

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".

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp
Address: 105 Morgan Ln, Plainsboro, New Jersey 08536-3339

Distribution

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

Timeline

Recall initiated: 2012-04-04
Posted by FDA: 2012-07-10
Terminated: 2012-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109901. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.