Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pudenz Flushing Valve with Integral Connectors Recalled by Integra LifeSciences Corp Due to The pouch label of catalog NL850-1330 indicates an...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp directly.
Affected Products
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.
Quantity: 39 units
Why Was This 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".
Where Was This Sold?
International Only Distribution, including the countries of Thailand and Japan.
About Integra LifeSciences Corp
Integra LifeSciences Corp has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report