{ "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": "189566", "product_res_number": "Z-0231-2022", "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-12709-WC\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:\n13F19K0564 13F20C0094 13F20G0284 13F20L0282 13F21A0497 13F21A0718\n13X21E0008 13F21F1187", "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\nembolization 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": "447 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": [ "K832023", "K883852", "K971314", "K780762", "K992940", "K920871", "K961716", "K100840", "K163353", "K790838", "K950586", "K901627", "K864007", "K973477", "K970762", "K213771", "K233820", "K761031", "K832044", "K864330", "K901625", "K901502", "K972572", "K233619", "K780244", "K961992", "K850015", "K992933", "K152335", "K961883", "K891021", "K954760", "K193379", "K163031", "K982141", "K974335", "K840198", "K820646", "K905139", "K935405", "K801650", "K897184", "K902327", "K973465", "K894681", "K241330", "K910372", "K011783", "K992934", "K893680", "K233819", "K864062", "K853625", "K955125", "K002627", "K202049", "K970657", "K892410", "K992368", "K972623", "K972511", "K020634", "K240078", "K081573", "K881455", "K914880", "K872485", "K812640", "K770714", "K770569", "K100842", "K920823", "K022145", "K900311" ], "registration_number": [ "3015859709", "", "3009051888", "9615817", "1018233", "2024311", "1721686", "1220948", "3045042524", "2648045", "2522007", "2029386", "3032916632", "3006082230", "1721504", "2027111", "3008496528", "2183744", "3012050423", "1319639", "1220452", "8043983", "9680794", "3010041511", "3011137372", "9617465", "1061124", "3013666218", "1000393132", "3005704822", "1820334", "2015691", "3035111606", "2183870", "3030714660" ], "fei_number": [ "3015859709", "", "1000306647", "3003769549", "1000138054", "3009051888", "3005747797", "1018233", "2024311", "1721686", "1220948", "3045042524", "2648045", "3003081151", "2522007", "3032916632", "3006082230", "1721504", "2027111", "3008496528", "3016261803", "2183744", "3012050423", "3003737899", "1000512168", "1220452", "3010041511", "3013666218", "1000393132", "3005704822", "1820334", "2015691", "3035111606", "2183870", "3030714660" ], "device_name": "Catheter, Embolectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5150", "device_class": "2" } } ] }