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.
Recall
- Recall Number
- Z-0566-2016
- Event Number
- 72712
- Firm
- Aesculap, Inc.
- FEI Number
- 2916714
- Product Code
- GAD
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- November 17, 2015
- Terminated
- October 13, 2016
- Address
- 3773 Corporate Pkwy, Center Valley, PA, 18034-8217
Description
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.
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
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: [email protected] 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 [email protected] 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 [email protected] or Product Manager at 610-984-9150 or email to [email protected].
US Distribution to state of: NY.
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