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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Fixt Suture Braided Polyester

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  Class 2 Device Recall Bard Fixt Suture Braided Polyester see related information
Date Initiated by Firm March 11, 2014
Date Posted May 07, 2014
Recall Status1 Open3, Classified
Recall Number Z-1559-2014
Recall Event ID 67711
510(K)Number K063778  K930738  
Product Classification Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
Product Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico.

Indicated for use in soft tissue approximation.
Code Information Product Code H5300 - Lot 1450153E13
Recalling Firm/
Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Michael T. Taggart
Manufacturer Reason
for Recall
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
FDA Determined
Cause 2
Under Investigation by firm
Action Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990.
Quantity in Commerce 32,271 ea.
Distribution Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GAT and Original Applicant = DEKNATEL, INC.
510(K)s with Product Code = GAT and Original Applicant = TELEFLEX MEDICAL