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.
- Company
- Aesculap Inc
- Recall Initiated
- December 23, 2013
- Posted
- February 19, 2014
- Terminated
- October 1, 2014
- Recall Number
- Z-0989-2014
- Quantity
- 79
- Firm Location
- Center Valley, PA
Reason for Recall
The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.
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.
Lot / Code Info
4 lots: 4505268906, 4505336973, 4505408485, 4505238953
Root Cause
Employee error
Action Taken
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.