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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Distaflo Vascular Bypass Graft

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  Class 2 Device Recall Bard Distaflo Vascular Bypass Graft see related information
Date Initiated by Firm January 05, 2016
Date Posted February 09, 2016
Recall Status1 Terminated 3 on March 25, 2016
Recall Number Z-0785-2016
Recall Event ID 73022
510(K)Number K983861  
Product Classification Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
Product Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm.
Intended for bypass or reconstruction of peripheral arterial blood vessels.
Code Information Product Code: DF6006SC Lot Number: VTZE1782  
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St
Tempe AZ 85281-2438
For Additional Information Contact
800-321-4254
Manufacturer Reason
for Recall		 Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
FDA Determined
Cause 2		 Error in labeling
Action Customer notification letters were sent on 01/05/2016. Customers were asked to not use the affected product, or further distribute it. Customers were asked to check all inventory locations for the affected product code, lot number combination listed. If customers further distributed any of the product they are requested to contact that location, advise them of the recall, and forward the listed instructions. The letter states to remove all identified product from the shelves. If no affected product is going to be returned the firm states to complete and return the attached form stating so. If customers have product it is requested that they also complete the attached form, and state the quantities and lot numbers in stock. The letter requests that customers call the firm's Recall Coordinator, Raye Seisinger, at 1-800-321-4254, option #2 ext. 2501 (M-F 6am to 3pm MST) or email raye.seisinger@crbard.com. Once all information has been verified the customer will be issued a Return Authorization or Consignment Recall Number to facilitate the expedient return of the product. The firm will provide replace product for returned product. Fax the attached form to the firm at 1-800-994-6772. If the customer cannot fax the firm they request that the Recall Coordinator be contact and provided the information verbally. The letter states a mailing label is enclosed to return the affected product. Customers are requested to amek the package as "recalled product" and include the XC or XH number. All products should be returned to the following shipping address: Bard Peripheral Vascular, Inc. 1415 W. 3rd St. Tempe, AZ 85281
Quantity in Commerce 4 units
Distribution Distributed in the states of AL, TX, and CA.
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 = IMPRA, INC.
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