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U.S. Department of Health and Human Services

Class 2 Device Recall Pudenz Flushing Valve

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  Class 2 Device Recall Pudenz Flushing Valve see related information
Date Initiated by Firm April 04, 2012
Date Posted July 10, 2012
Recall Status1 Terminated 3 on August 02, 2012
Recall Number Z-1984-2012
Recall Event ID 62138
510(K)Number K760501  
Product Classification Shunt, central nervous system and components - Product Code JXG
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.
Code Information 1115647, 1115939, 1120413
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp
105 Morgan Ln
Plainsboro NJ 08536-3339
For Additional Information Contact
609-275-2700
Manufacturer 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".
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JXG and Original Applicant = HEYER SCHULTE CORP.
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