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U.S. Department of Health and Human Services

Class 2 Device Recall AesculapMiethke Shunt System

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  Class 2 Device Recall AesculapMiethke Shunt System see related information
Date Initiated by Firm October 24, 2014
Date Posted December 03, 2014
Recall Status1 Terminated 3 on May 20, 2015
Recall Number Z-0502-2015
Recall Event ID 69600
510(K)Number K011030  
Product Classification Shunt, central nervous system and components - Product Code JXG
Product The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Code Information Item Number FV129 Lot Number 4506244166 Serial Number A10150
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, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. However, the expiration date on the outer box was correct. No patient injuries were reported as a result of this issue.
FDA Determined
Cause 2		 Labeling mix-ups
Action An important correction & removal notification letter, dated October 24, 2014, was sent to the sole consignee who received the affected device. The letter identified the product, problem, and action to be taken.
Quantity in Commerce 1
Distribution US Distribution in Kansas only.
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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