U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Retractor - Product Code GAD
원인
Aag received a customer complaint that corrosion had been found by a hospitals central sterile service department on the ball joint of an fc424r blade. investigation revealed that the corrosion was due to incorrect material used in the manufacturing of the disk spring of the ball joint by the supplier.
조치
The firm, Aesculap, sent an "URGENT MEDICAL DEVICE CORRECTION OR REMOVAL" letter dated 11/17/2015 to its customer. The letter described the product, problem and actions to be taken. The customer was instructed to review the product recall notification in its entirety; do not destroy any affected product; if you have no inventory remaining, notate that on the Product Removal Acknowledgement Form; contact our customer service department for an RGR at 866-229-3002 or email: SetWorld_Orders.BBMUS_Service@aesculap.com and immediately return affected product; complete and return the Product Removal Acknowledgement Form to Aesculap Quality Assurance department by fax to 610-791-6882 or email to val.strawn@Aesculap.com within two(2) weeks of receipt, even if the total inventory in your possession is zero (0)
Sales Representative will make an appointment to come and exchange the effected product with an interium solution (FC360-Atrium Lift Retractor Set) that will allow any scheduled or unexpected cases, which would require the use of this product. The newly manufactured product will ship automatically when it's available.Then a visit will be scheduled to retrieve the loaner FC360R sets.
If you have any questions, contact Quality Specialist at 610-984-9414 or email to val.strawn@aesculap.com or Product Manager at 610-984-9150 or email to mark.eppedio@aesculap.com.
Valve XS Atrium Retractor || FC429R || 52154756 || The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.