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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap

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  Class 2 Device Recall Aesculap see related information
Date Initiated by Firm December 23, 2013
Date Posted February 19, 2014
Recall Status1 Terminated 3 on October 01, 2014
Recall Number Z-0989-2014
Recall Event ID 67174
510(K)Number K120559  
Product Classification Shunt, central nervous system and components - Product Code JXG
Product Aesculap proSA Adjustment Disc Size Large (L)

The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

Code Information 4 lots: 4505268906, 4505336973, 4505408485, 4505238953
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		 The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
FDA Determined
Cause 2		 Employee error
Action Aesculap sent an Important Correction and Removal Notification dated December 23, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.. Yom"Aesculap Sales Representative will contact you to schedule a time to remove the FV795T from Set FV792T. Please use FV790T in the absence of the FV795T to ensure the correct adjustment has been made. Please complete the attached Inventory Sheet which is necessary to comply with FDA regulations. When completing the inventory sheet, please fill in the quantity being returned. If you cannot locate the product, please provide an explanation as to why the inventory will not be returned (discarded, etc.). AIC (USA) appreciates your cooperation on this matter and apologizes for the inconvenience this may cause. Thank you for your patience and continued support of this product. Please call (610) 984-9265 or (610) 984-9414 with any questions.
Quantity in Commerce 79
Distribution Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway 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 = AESCULAP, INC.
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