| Date Initiated by Firm |
November 17, 2015 |
| Create Date |
December 31, 2015 |
| Recall Status1 |
Terminated 3 on October 13, 2016 |
| Recall Number |
Z-0566-2016 |
| Recall Event ID |
72712 |
| Product Classification |
Retractor - Product Code GAD
|
| Product |
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. |
| Code Information |
Product Information All lots affected Product Description FC424R Valve XS Atrium Lift Ret. Blade50X35 FC425R Valve XS Atrium Lift Ret. Blade60X35 FC426R Valve XS Atrium Lift Ret. Blade70X35 FC428R Valve XS Atrium Lift Ret. Blade50X45 FC429R Valve XS Atrium Lift Ret. Blade60X45 FC430R Valve XS Atrium Lift Ret. Blade70X45 FC431R Valve XS Atrium Lift Ret. Blade25X20 FC432R Valve XS Atrium Lift Ret. Blade25X25 FC433R Valve XS Atrium Lift Ret. Blade40X25 FC434R Valve XS Atrium Lift Ret. Blade50X25 FC435R Valve XS Atrium Lift Ret. Blade25X40 FC436R Valve XS Atrium Lift Ret. Blade25X50 FC420R Valve XS Atrium Lift Ret. Blade Complete Set |
Recalling Firm/
Manufacturer |
Aesculap, Inc.
3773 Corporate Pkwy
Center Valley PA 18034-8217
|
| For Additional Information Contact |
800-258-1946 Ext. 5067
|
Manufacturer Reason
for Recall |
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
|
FDA Determined
Cause 2 |
Mixed-up of materials/components |
| Action |
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. |
| Quantity in Commerce |
41 |
| Distribution |
US Distribution to state of: NY. |
| 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.
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