{ "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": "190148", "product_res_number": "Z-0311-2022", "event_date_initiated": "2021-10-14", "event_date_created": "2021-11-29", "recall_status": "Open, Classified", "res_event_number": "88972", "product_code": "DWF", "k_numbers": [ "K160257" ], "product_description": "SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass.\nIncluding the following components:\na) 31 Fr ProtekDuo Veno-Venous Cannula Set\nb) LifeSPARC Pump\nc) 14Fr to 26 Fr Dilator Set\nd) TandemHeart Wrap.\n\nKit Number: 5820-3118\n\nIntended use is applicable to the intended use of specific devices included in the kit.", "code_info": "Serial Numbers:\t\n872170,\t\n872171,\t\n872172,\t\n872173,\t\n872182,\t\n872183,\t\n872184.\t\n\nUDI: \n\t\n01)00814112020791(17)220\n501(22)220511(21) 872170;\t\n(01)00814112020791(17)220\n501(22)220511(21) 872171;\t\n(01)00814112020791(17)220\n501(22)220511(21) 872172;\t\n(01)00814112020791(17)220\n501(22)220511(21) 872173;\t\n(01)00814112020791(17)220\n501(22)220511(21) 872182;\n(01)00814112020791(17)220\n501(22)220511(21) 872183;\n01)00814112020791(17)220\n501(22)220511(21) 872184", "firm_fei_number": "3002228812", "recalling_firm": "Cardiac Assist, Inc", "address_1": "240 Alpha Dr", "city": "Pittsburgh", "state": "PA", "postal_code": "15238-2906", "additional_info_contact": "Marnie Smith \n412-963-7770 Ext. 227", "reason_for_recall": "Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)", "root_cause_description": "Error in labeling", "action": "LiNova issued an \"URGENT MEDICAL DEVICE REMOVAL\" letter (FA-CP-PIT-2021-003) dated October 13th, 2021 via e-mail on 14 October 2021. Letter states reason for recall, health risk and action to take:\nTandemLife recommends using the device as labelled and dispose the outer packaging.\nTandemLife kindly requests your execution of the following actions:\n1. Using attached Response Form in Attachment 1 of this letter, please:\n- If you have already discarded of outer packaging prior to the receipt of this letter, please proceed to step 2\n- Check your inventory for the presence of potentially affected kit contained within your\nordered kit as per Table provided in Attachment 1;\n- Please dispose of the outer packaging of your impacted product upon notification\nof this letter.\n- Please use your devices as labelled on the device level labeling.\n2. Return the attached Response Form in Attachment 1 by email to\nLivaNova.FSCA@livanova.com to confirm appropriate corrective actions have been\nexecuted. Please return the Response Form even if each potentially affected device listed in Attachment 1 has already been used.\n\nFor questions regarding this Medical Device Removal, please contact your TandemLife\nrepresentative, or TandemLife Customer Quality at LivaNova.FSCA@livanova.com.", "product_quantity": "7 units", "distribution_pattern": "US Distribution to states of: DC, MA, SC, and VA.", "openfda": { "k_number": [ "K250937", "K880779", "K881352", "K971023", "K955121", "K883412", "K140165", "K834134", "K152161", "K901074", "K880421", "K110980", "K171979", "K970914", "K802261", "K890024", "K020693", "K081820", "K033264", "K801397", "K990772", "K880180", "K840914", "K090878", "K023880", "K131269", "K854640", "K001371", "K010737", "K062597", "K844140", "K043179", "K801396", "K964195", "K832124", "K895352", "K030696", "K014303", "K930684", "K791832", "K896777", "K022272", "K052081", "K910021", "K972261", "K180979", "K801770", "K151523", "K991170", "K865079", "K905638", "K133445", 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