Z-1984-2012Class II

Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro...

Name: Z-1984-2012 Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro...
Creator: Integra LifeSciences Corp
Published: 2012-04-04
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2012-04-04 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp began a recall of Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of... on 2012-04-04. FDA classified it as Class II and gives the reason as "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"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1984-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-04
Posted: 2012-07-10
Terminated: 2012-08-02
Recalling firm: Integra LifeSciences Corporation
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.
Product code: JXG Shunt, Central Nervous System And Components
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".
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 39 units
Distribution: International Only Distribution, including the countries of Thailand and Japan.
Product codes and lots: 1115647, 1115939, 1120413

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1984-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1984-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-10

Product code JXG

K760501Class IIValve, Standard Model Pudenze FlushingHeyer Schulte Corp. / cleared 1976-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)