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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap(R) Miethke Shunt System

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 Class 2 Recall
Aesculap(R) Miethke Shunt System
see related information
Date Posted February 12, 2013
Recall Status1 Terminated on January 08, 2014
Recall Number Z-0805-2013
Recall Event ID 63244
Premarket Notification
510(K) Numbers
K020728  K110030  K110206 
Product Classification Shunt, Central Nervous System And Components - Product Code JXG
Product Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Code Information Lots 4503489878, 4503792749, 4503682927, 4503508385, 4503789879, 4503800248 and 4503682935.
Recalling Firm/
Manufacturer
Aesculap, Inc.
3773 Corporate Pkwy
Center Valley, Pennsylvania 18034-8217
Manufacturer Reason
for Recall
The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Aesculap sent an Important Recall Notification letter dated June 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the contact their local sales representative or customer service department at 1-800-282-9000 to return the affected product. Customers were also instructed to complete the Inventory Sheet attached to the letter with the quantity being returned. If customers could not locate the affected product they should provide an explanation as to why the inventory will not be returned. Customers with questions should call 610-984-9251 or 610-984-9291. For questions regarding this recall call 1-800-234-9179, ext 5067.
Quantity in Commerce 11
Distribution Nationwide Distribution including MI, PA and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JXG and Original Applicant = AESCULAP, INC.
510(K)s with Product Code = JXG and Original Applicant = BOSTON SCIENTIFIC CORP.
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