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U.S. Department of Health and Human Services

Class 3 Device Recall Aesculap Miethke Shunt System, miniNAV Valve

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  Class 3 Device Recall Aesculap Miethke Shunt System, miniNAV Valve see related information
Date Initiated by Firm November 11, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on June 09, 2015
Recall Number Z-0814-2015
Recall Event ID 69741
510(K)Number K110206  
Product Classification Shunt, central nervous system and components - Product Code JXG
Product Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Code Information Catalog No: FV660T Lot No: 4506022655  
Recalling Firm/
Manufacturer		 Aesculap, Inc.
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Customer Support
800-258-1946 Ext. 5067
Manufacturer Reason
for Recall		 Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System accessories due to missing patients' labels for the miniNAV (FV660T). There are no patient injuries resulting from this issue.
FDA Determined
Cause 2		 Labeling Change Control
Action An important correction & removal notification, dated November 11, 2014, was sent to consignees that identified the product, problem, and action to be taken. Consignees were asked to complete the distribution inventory sheet and return it. Aesculap sales representatives would be coordinating pick up of affected devices.
Quantity in Commerce 4
Distribution Distributed in OK, and WI.
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 = AESCULAP, INC.
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