FDAClass IIJuly 18, 2012

Pudenz Flushing Valve with Integral Connectors recall

Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of…

Why was Pudenz Flushing Valve with Integral Connectors 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".

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1115647, 1115939, 1120413

Product
Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of…
Recalling firm
Integra LifeSciences Corp
Quantity
39 units
Distribution
International Only Distribution, including the countries of Thailand and Japan.
Recall date
July 18, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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