{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189567", "product_res_number": "Z-0232-2022", "event_date_initiated": "2021-09-20", "event_date_posted": "2021-11-18", "recall_status": "Terminated", "event_date_terminated": "2023-10-05", "res_event_number": "88796", "product_code": "DXE", "k_numbers": [ "K011056" ], "product_description": "Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR\nProduct Code: PT-65709-HFWC\n\nThe Arrow-Trerotola\" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts", "code_info": "Lot Number:\n13F19K0369 13F20A0323 13F20B0139 13F20C0594 13F20F0083 13F20F0230\n13F20F0577 13F20H0756 13F20K0849 13F20L0283 13F20M0182 13F21A0498\n13F21B0158 13F21C0747 13F21E0555", "firm_fei_number": "3015859709", "recalling_firm": "Arrow International Inc", "address_1": "2400 Bernville Rd", "city": "Reading", "state": "PA", "postal_code": "19605-9607", "additional_info_contact": "SAME\n610-378-0131", "reason_for_recall": "7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.", "root_cause_description": "Unknown/Undetermined by firm", "action": "Arrow International, a subsidiary of Teleflex issued an \"URGENT - FIELD SAFETY NOTICE\" consignee notification letter on 20th Sept 2021 via FedEx 2-day mail to medical facilities and distributors. Letter states reason for recall, health risk and action to take:\nWe request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately.\n2. If you do not have stock in scope of this FSCA mark the according checkbox on the\nAcknowledgement Form (Appendix 1) and return the form to the fax number or e-mail address\nmentioned below.\n3. If you do have stock in scope of this FSCA, complete the Acknowledgement Form (Appendix 1) and fax it to 1-855-419-8507, Attn: Customer Service or e-mail 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.\n\nDistributors\n1. Provide this field safety notice to all customers who have received product in scope of this FSCA. Your customer is then required to complete the Acknowledgement Form and return to you.\n\nShould you require any further information or support concerning this issue, please contact: Customer Service Telephone: 1-866-396-2111; FAX: 1-855-419-8507 or E-mail: Recalls@teleflex.com.", "product_quantity": "1245 units", "distribution_pattern": "Worldwide distribution: US (Nationwide) and OUS\n(Foreign) to countries of:\nBE\nCA\nCL\nCZ\nDE\nES\nFR\nIL\nIT\nKR\nPH\nSA\nTR\nTW\nUK", "openfda": { "k_number": [ "K900311", "K202049", "K954760", "K897184", "K864062", "K020634", "K973465", "K935405", "K812640", "K891021", "K883852", "K920823", "K971314", "K914880", "K081573", "K972511", "K240078", "K163353", "K193379", "K992368", "K100842", "K902327", "K910372", "K872485", "K241330", "K850015", "K022145", "K901502", "K950586", "K982141", "K972623", "K832023", "K853625", "K770569", "K970657", "K901625", "K894681", "K920871", "K973477", "K780762", "K801650", "K972572", "K961716", "K233820", "K011783", "K992934", "K780244", "K905139", "K864330", "K163031", "K761031", "K961883", "K955125", "K213771", "K832044", "K892410", "K992933", "K152335", "K233819", "K961992", "K790838", "K881455", "K970762", "K820646", "K901627", "K893680", "K233619", "K840198", "K864007", "K770714", "K992940", "K002627", "K974335", "K100840" ], "registration_number": [ "", "3013666218", "3015859709", "2024311", "9617465", "1061124", "1220948", "3011137372", "3030714660", "1220452", "3035111606", "1000393132", "2027111", "3010041511", "1018233", "1721686", "3005704822", "3008496528", "2029386", "1319639", "2183744", "8043983", "1721504", "3032916632", "9680794", "3006082230", "9615817", "2522007", "2015691", "3009051888", "2183870", "1820334", "2648045", "3012050423" ], "fei_number": [ "", "1000138054", "3013666218", "3015859709", "2024311", "3003081151", "1220948", "1220452", "3030714660", "3035111606", "3016261803", "1000393132", "2027111", "3003769549", "3010041511", "1018233", "1721686", "3005704822", "3008496528", "1000512168", "3003737899", "2183744", "1000306647", "1721504", "3032916632", "3005747797", "3006082230", "2522007", "2015691", "3009051888", "2183870", "1820334", "2648045", "3012050423" ], "device_name": "Catheter, Embolectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5150", "device_class": "2" } } ] }