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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap Miethke Shunt System

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  Class 2 Device Recall Aesculap Miethke Shunt System see related information
Date Initiated by Firm December 17, 2014
Date Posted January 26, 2015
Recall Status1 Terminated 3 on December 13, 2016
Recall Number Z-1012-2015
Recall Event ID 70086
510(K)Number K120559  
Product Classification Shunt, central nervous system and components - Product Code JXG
Product Miethke Shunt System accessories

Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

Code Information material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T 
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		 Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).
FDA Determined
Cause 2		 Labeling False and Misleading
Action Aesculap sent an Important Correction and Removal and Field Safety Notification letter, dated December 17, 2014, to all affected customers. The letter identiifed the affected product, problem, and actions to be taken. Customers were requested to remove from inventory and contact Aesculap regarding return of the affected devices and acknowledgement form.
Quantity in Commerce 772
Distribution Worldwide Distribution - US Nationwide
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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