{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "158986", "product_res_number": "Z-0083-2018", "event_date_initiated": "2017-10-05", "event_date_created": "2017-11-09", "recall_status": "Terminated", "event_date_terminated": "2023-01-20", "res_event_number": "78242", "product_code": "FZP", "k_numbers": [ "K152081" ], "product_description": "WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO", "code_info": "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", "firm_fei_number": "3005747797", "recalling_firm": "Teleflex Medical", "address_1": "2917 Weck Dr", "city": "Research Triangle Park", "state": "NC", "postal_code": "27709-0186", "additional_info_contact": "847-572-8014", "reason_for_recall": "The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.", "root_cause_description": "Under Investigation by firm", "action": "The firm initiated their recall on 05 OCT 2017 via FedEx 2-day.\n\nThe letter requested the following actions to be taken by hospitals to remove product from the facilities:\n\n\"1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above.\n2. 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.\n3. 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.\"\n\nDistributors were instructed as follows:\n\n\"1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above.\n2. 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.\n3. 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.\n4. To return recalled products to Teleflex Medical, complete the enclosed Recall\nAcknowledgement 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 (", "product_quantity": "13,710 units", "distribution_pattern": "Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. 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"3010605922" ], "device_name": "Clip, Implantable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4300", "device_class": "2" } } ] }