Date Initiated by Firm | June 04, 2012 |
Date Posted | February 12, 2013 |
Recall Status1 |
Terminated 3 on January 08, 2014 |
Recall Number | Z-0805-2013 |
Recall Event ID |
63244 |
510(K)Number | K020728 K110206 |
Product Classification |
Shunt, central nervous system and components - Product Code JXG
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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 PA 18034-8217
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For Additional Information Contact | 800-258-1946 Ext. 5067 |
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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = JXG
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