{ "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": "191576", "product_res_number": "Z-0629-2022", "event_date_initiated": "2022-01-11", "event_date_posted": "2022-02-15", "recall_status": "Terminated", "event_date_terminated": "2024-09-11", "res_event_number": "89390", "product_code": "QEW", "k_numbers": [ "K011056" ], "product_description": "Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) \n\nThe Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.", "code_info": "Lot Number / UDI:\n13F20A0286 / (01)00801902013156(17)211231(10)13F20A0286; \nLot Number / UDI:\n13F20A0426 / (01)00801902013156(17)211231(10)13F20A0426; \nLot Number / UDI:\n13F20A0640 / (01)00801902013156(17)220131(10)13F20A0640; \nLot Number / UDI:\n13F20B0141 / (01)00801902013156(17)220131(10)13F20B0141; \nLot Number / UDI:\n13F20B0276 / (01)00801902013156(17)220228(10)13F20B0276; \nLot Number / UDI:\n13F20B0353 / (01)00801902013156(17)220228(10)13F20B0353; \nLot Number / UDI:\n13F20B0424 / (01)00801902013156(17)220228(10)13F20B0424; \nLot Number / UDI:\n13F20C0352 / (01)00801902013156(17)220228(10)13F20C0352; \nLot Number / UDI:\n13F20C0425 / (01)00801902013156(17)220331(10)13F20C0425; \nLot Number / UDI:\n13F20C0426 / (01)00801902013156(17)220331(10)13F20C0426; \nLot Number / UDI:\n13F20D0122 / (01)00801902013156(17)220331(10)13F20D0122; \nLot Number / UDI:\n13F20D0123 / (01)00801902013156(17)220430(10)13F20D0123; \nLot Number / UDI:\n13F20D0124 / (01)00801902013156(17)220331(10)13F20D0124; \nLot Number / UDI:\n13F20D0403 / (01)00801902013156(17)220430(10)13F20D0403; \nLot Number / UDI:\n13F20E0204 / (01)00801902013156(17)220430(10)13F20E0204; \nLot Number / UDI:\n13F20F0232 / (01)00801902013156(17)220531(10)13F20F0232; \nLot Number / UDI:\n13F20F0389 / (01)00801902013156(17)220630(10)13F20F0389; \nLot Number / UDI:\n13F20G0353 / (01)00801902013156(17)220630(10)13F20G0353; \nLot Number / UDI:\n13F20H0729 / (01)00801902013156(17)220831(10)13F20H0729; \nLot Number / UDI:\n13F20J0378 / (01)00801902013156(17)220831(10)13F20J0378; \nLot Number / UDI:\n13F20J0546 / (01)00801902013156(17)220831(10)13F20J0546; \nLot Number / UDI:\n13F20J0771 / (01)00801902013156(17)220831(10)13F20J0771; \nLot Number / UDI:\n13F20K0503 / (01)00801902013156(17)220930(10)13F20K0503; \nLot Number / UDI:\n13F20K0504 / (01)00801902013156(17)220930(10)13F20K0504; \nLot Number / UDI:\n13F20K0630 / (01)00801902013156(17)220930(10)13F20K0630; \nLot Number / UDI:\n13F20K0631 / (01)00801902013156(17)220930(10)13F20K0631; \nLot Number / UDI:\n13F20M0175 / (01)00801902013156(17)221130(10)13F20M0175; \nLot Number / UDI:\n13F20M0176 / (01)00801902013156(17)221130(10)13F20M0176; \nLot Number / UDI:\n13F20M0177 / (01)00801902013156(17)221130(10)13F20M0177; \nLot Number / UDI:\n13F20M0178 / (01)10801902013153(17)221130(10)13F20M0178; \nLot Number / UDI:\n13F20M0181 / (01)00801902013156(17)221231(10)13F20M0181; \nLot Number / UDI:\n13F21A0352 / (01)00801902013156(17)221231(10)13F21A0352; \nLot Number / UDI:\n13F21B0159 / (01)00801902013156(17)230131(10)13F21B0159; \nLot Number / UDI:\n13F21B0222 / (01)00801902013156(17)230131(10)13F21B0222; \nLot Number / UDI:\n13F21B0519 / (01)10801902013153(17)230228(10)13F21B0519; \nLot Number / UDI:\n13F21C0364 / (01)00801902013156(17)230228(10)13F21C0364; \nLot Number / UDI:\n13F21C0365 / (01)00801902013156(17)230228(10)13F21C0365; \nLot Number / UDI:\n13F21D0462 / (01)00801902013156(17)230331(10)13F21D0462; \nLot Number / UDI:\n13F21E0079 / (01)00801902013156(17)230430(10)13F21E0079; \nLot Number / UDI:\n13F21E0259 / (01)00801902013156(17)230430(10)13F21E0259; \nLot Number / UDI:\n13F21E0260 / (01)00801902013156(17)230430(10)13F21E0260; \nLot Number / UDI:\n13F21E0556 / (01)00801902013156(17)230430(10)13F21E0556; \nLot Number / UDI:\n13F21F0641 / (01)00801902013156(17)230531(10)13F21F0641; \nLot Number / UDI:\n13F21G0227 / (01)00801902013156(17)230630(10)13F21G0227; \nLot Number / UDI:\n13F21G0401 / (01)00801902013156(17)230630(10)13F21G0401; \nLot Number / UDI:\n13F21G0772 / (01)00801902013156(17)230630(10)13F21G0772; \nLot Number / UDI:\n13F21H0447 / (01)10801902194074(17)230731(10)13F21H0447; \nLot Number / UDI:\n13F21K0827 / (01)10801902194074(17)231031(10)13F21K0827; \nLot Number / UDI:\n13F21K0898 / (01)10801902194074(17)231031(10)13F21K0898; \nLot Number / UDI:\n13F21L0227 / (01)20801902194071(17)231031(10)13F21L0227; \nLot Number / UDI:\n13F21L0507 / (01)10801902194074(17)231031(10)13F21L0507; \nLot Number / UDI:\n13F21L0898 / (01)10801902194074(17)231031(10)13F21L0898", "firm_fei_number": "3005747797", "recalling_firm": "TELEFLEX MEDICAL INC", "address_1": "3015 Carrington Mill Blvd", "city": "Morrisville", "state": "NC", "postal_code": "27560-5437", "reason_for_recall": "The firm received reports indicating PTD tip separation during use.", "root_cause_description": "Process change control", "action": "Arrow International LLC/Teleflex notified their consignees by letter on 01/11/2022. The letter explained the issue and requested that the consignee cease use and distribution. Distributors were directed to notify their customers. The firm is seeking return of the affected product. The following instructions were provided:\n\nAction list number 1 Medical facilities \n1. We 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 mentioned 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\nAction list number 2 Distributors \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.\n2. We request that you check your inventory for product within the scope of this FSCA. Cease use and distribution of impacted product and quarantine immediately. You may then return all product in scope to Teleflex.\n3. As a distributor, you are then required to confirm to Teleflex that you have completed the field activity outlined above. Upon completion of your actions, please forward the completed Acknowledgement Form to Customer Service. Important - Please ensure you only list batch numbers in scope of this Field Safety Notice when completing this form.\n4. If you have further distr", "product_quantity": "14583 units", "distribution_pattern": "Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.", "openfda": { "k_number": [ "K230743", "K192833", "K182835", "K141617", "K241207", "K180412", "K191368", "K192332", "K240030", "K241362", "K180722", "K163549", "K083370", "K142870", "K173470", "K220780", "K252612", "K210323", "K221204", "K183179", "K212632", "K233917", "K251185", "K251949", "K251485", "K230356", "K133629", "K143563", "K210083", "K230494", "K223216", "K162970", "K991093", "K011056", "K233909", "K223210", "K202345", "K202218", "K231848", "K201216", "K180466", "K210911", "K250421", "K251207", "K253323", "K260599", "K182531", "K200314", "K252956", "K250668", "K210530", "K233815", "K191710", "K220887", "K021641", "K152097", "K193244", "K230331", "K193462", "K220600", "K161506", "K231022", "K201705", "K242075", "K221391", "K192814", "K203476", "K222358", "K251189", "K173672", "K182167", "K183198", "K252057", "K223897", "K214114", "K241399", "K220415", "K180329", "K092623", "K090932", "K241894", "K250775", "K211013", "K200101", "K210689", "K210195", "K132281", "K193595", "K200771", "K250202", "K201541", "K161523", "K213402", "K232679", "K080901", "K261523", "K182233", "K250787", "K220501", "K223891", "K223613", "K040010", "K160533", "K242319", "K230030", "K211492", "K253730", "K234073", "K234034", "K210190", "K223436", "K192935", "K181325", "K251070", "K242557", "K172716", "K221531", "K181694", "K260028", "K121917", "K232730", "K192036", "K223419", "K230912", "K223000", "K203333", "K211798", "K201085", "K220270", "K202821", "K130381", "K151313", "K192981", "K223929", "K240117", "K223609", "K180939", "K223186", "K250088", "K180105", "K041374", "K220683" ], "registration_number": [ "3013758550", "3031976597", "2011171", "1424778", "3027226463", "1000121056", "3019807891", "1225687", "3017210488", "3004832480", "3031823122", "1644312", "2032098", "3011471056", "1000523114", "3008439199", "3014687026", "3020256033", "3029444898", "3004111573", "3020347218", "9616684", "3011642792", "3010220595", "2124215", "3040801290", "3004198398", "1048735", "3030481118", "3010047454", "3025465918", "3005168196", "3015615738", "2648729", "3007695959", "3004737415", "2022435", "1721676", "2244478", "2183744", "3008114965", "3006946276", "1064858", "3015924373", "3004859241", "3010273872", "3034619061", "3008700817", "2020394", "3004593495", "3016591327", "2030624", "3005160949", "3002807314", "1724474", "3010041511", "3014498720", "9681260", "3011137372", "3013944123", "3026567963", "3009380063", "3008514120", "2134265", "3010034260", "3017823876", "3016704395", "1625425", "3014590708", "3014787927", "1319211", "9612164" ], "fei_number": [ "1000117748", "3013758550", "3031976597", "2011171", "3005747797", "3027226463", "1000121056", "3019807891", "3017210488", "3004832480", "3031823122", "3011471056", "1000523114", "3008439199", "3001451463", "3014687026", "3020256033", "3008397795", "3029444898", "3004111573", "1000136269", "3020347218", "3011642792", "3010220595", "2124215", "3040801290", "3004198398", "3002095335", "3030481118", "3010047454", "3025465918", "1048735", "3002913962", "3005168196", "3015615738", "2648729", "3007695959", "3002806565", "2022435", "1721676", "3003473227", "3003094851", "3004737415", "2183744", "3008114965", "3006946276", "3002806434", "3015924373", "3004859241", "3010273872", "3034619061", "3008700817", "3000206435", "2020394", "3016591327", "3004593495", "3005160949", "3002807314", "3010041511", "3026567963", "3014498720", "3013944123", "3003058448", "3009380063", "3008514120", "3010034260", "3017823876", "3016704395", "1625425", "3014590708", "3014787927", "1319211" ], "device_name": "Peripheral Mechanical Thrombectomy With Aspiration", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5150", "device_class": "2" } } ] }