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U.S. Department of Health and Human Services

Class 2 Device Recall EXXCEL Soft Standard Wall EPTFE Vascular Graft

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  Class 2 Device Recall EXXCEL Soft Standard Wall EPTFE Vascular Graft see related information
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  K0962433  
Product Classification Vascular Graft Prosthesis (6mm and greater diameter) - Product Code DSY
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
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.
510(K) Database 510(K)s with Product Code = DSY and Original Applicant = BOSTON SCIENTIFIC CORP.
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