Recall Z-1984-2012— Integra LifeSciences Corp

Name: FDA recall Z-1984-2012
Creator: U.S. Food and Drug Administration
Published: 2012-04-04

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp, initiated 2012-04-04, terminated 2012-08-02. It names one FDA 510(k) clearance: K760501. 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.. Reason: 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"..

Recalling firm: Integra LifeSciences Corp
Classification: Class II
Status: Terminated
Initiated: 2012-04-04
Terminated: 2012-08-02
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K760501 — VALVE, STANDARD MODEL PUDENZE FLUSHINGHeyer Schulte Corp.·cleared 1976-08-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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".

Data sourced from openFDA. This site is unofficial and independent of the FDA.