Class 2 Device Recall Percuvance Clip Applier Tool Tip

• Date Initiated by Firm: July 19, 2017
• Create Date: September 27, 2017
• Recall Status: Terminated on October 06, 2020
• Recall Number: Z-3220-2017
• Recall Event ID: 77974
• 510(K)Number: K153063
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
• Code Information: Lot #'s: 73A1600601, 73A1700239, 73C1600705, 73E1600177, 73E1600177, 73E1600341, 73F1600411, 73F1600695, 73G1600727, 73H1600151, 73H1600342, and 73H1600660
• Recalling Firm/ Manufacturer: Teleflex Medical; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• For Additional Information Contact: Customer Service; 855-419-8507
• Manufacturer Reason for Recall: For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.
• FDA Determined Cause: Device Design
• Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated July 19 , 2017, to all affected consignees communicating the following on their recall of Percuvance Percutaneous Surgical System: Consignees were advised to take the following actions. 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. Customers with any other questions, should contact their local sales representative or Customer Service at 1-866-246-6990.
• Quantity in Commerce: 20,039 total (US and OUS)
• Distribution: Worldwide Distribution - US including AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Internationally to United Arab Emirates, Vienna, Australia, Belgium, Switzerland, China, Germany, Czech Republic, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iran, Italy, Japan, South Korea, R¿publique du Liban, Netherlands, Norway, Qatar, Romania, Saudi Arabia, Republic of Singapore, Turkey, Taiwan, and South Africa
• 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 = GEI