Class 2 Device Recall Deklene sutures

• Date Initiated by Firm: June 06, 2007
• Date Posted: July 17, 2007
• Recall Status: Terminated on March 14, 2008
• Recall Number: Z-1018-2007
• Recall Event ID: 38220
• 510(K)Number: K930738 K930739
• Product Classification: Sutures - Product Code GAM
• Product: Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123
• Code Information: Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123, Lot #35089.
• Recalling Firm/ Manufacturer: Teleflex Creek Dr; 4024 Stirrup Creek Dr; Durham NC 27703-9000
• For Additional Information Contact: Michael Crader; 919-433-4829
• Manufacturer Reason for Recall: Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
• Quantity in Commerce: 1920 units total for all types of sutures
• Distribution: Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
• 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 = GAM