Date Initiated by Firm | January 20, 2010 |
Date Posted | February 26, 2010 |
Recall Status1 |
Terminated 3 on July 06, 2010 |
Recall Number | Z-0866-2010 |
Recall Event ID |
54355 |
510(K)Number | K052964 |
Product Classification |
Vascular Graft Prosthesis (6mm and greater diameter) - Product Code DSY
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Product | EXXCEL Soft Standard Wall EPTFE Vascular Graft;
D:8 mm: L: 50 mm straight
Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470 |
Code Information |
Product Code: M002004910580; Lot # 12633379, Exp: 4/2012 |
Recalling Firm/ Manufacturer |
Maquet Cardiovascular, LLC 45 Barbour Pond Dr Wayne NJ 07470-2094
|
For Additional Information Contact | Dennis Genito 973-709-7515 |
Manufacturer Reason for Recall | Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, lot # 12633379 were mislabeled as Exxcel Soft Standard Wall Grafts. Bleeding could occur if wrong product is used. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Recall letters were sent to all US customers on January 20, 2010 by certified mail. Letters for foreign consignees were to be sent as soon as translation was completed. Customer are directed to call the company at 973-709-7515 for more information. |
Quantity in Commerce | 18 units |
Distribution | Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France. |
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 = DSY
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