FDAFDA · Food and drugs·Recall number Z-1984-2012
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.
Published July 18, 2012 · Recall initiated: April 4, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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".
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Integra LifeSciences Corp
- Distributor
- International Only Distribution, including the countries of Thailand and Japan.
- Lot
- 1115647, 1115939, 1120413
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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