Class 2 Device Recall WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hemolok(R) Clip Applier

• Date Initiated by Firm: October 05, 2017
• Create Date: November 09, 2017
• Recall Status: Terminated on January 20, 2023
• Recall Number: Z-0083-2018
• Recall Event ID: 78242
• 510(K)Number: K152081
• Product Classification: Clip, implantable - Product Code FZP
• Product: WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
• Code Information: Lot numbers: 73A1700701, 73H1600582, 73B1700183, 73H1600583, 73B1700567, 73H1600663, 73C1600069, 73H1600664, 73C1600070, 73H1600665, 73C1600071, 73H1600666, 73C1700288, 73H1600667, 73C1700289, 73H1600668, 73C1700290, 73J1600135, 73C1700292, 73J1600136, 73C1700300, 73J1600137, 73F1600036, 73J1600138, 73F1600037, 73J1600139, 73F1600038, 73J1600414, 73F1600039, 73J1600415, 73F1600040, 73J1600416, 73F1600689, 73K1600118, 73F1600690, 73K1600457, 73F1600691, 73K1600458, 73F1600692, 73K1600497, 73F1600693, 73K1600514, 73F1600694, 73K1600614, 73G1600151, 73L1600528, 73G1600431, 73L1600529, 73G1600432, 73L1600530, 73G1600716, 73L1600531, 73G1600717, 73L1600532, 73H1500014, 73L1600563, 73H1500015, 73M1600200, 73H1500016, 73M1600201, 73H1600173, 73M1600202, 73H1600174, 73M1600279
• Recalling Firm/ Manufacturer: Teleflex Medical; 2917 Weck Dr; Research Triangle Park NC 27709-0186
• For Additional Information Contact: 847-572-8014
• Manufacturer Reason for Recall: The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm initiated their recall on 05 OCT 2017 via FedEx 2-day. The letter requested the following actions to be taken by hospitals to remove product from the facilities: "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." Distributors were instructed as follows: "1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990. 4. To return recalled products to Teleflex Medical, 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 (
• Quantity in Commerce: 13,710 units
• Distribution: Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. Korea
• 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 = FZP