{ "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": "32270", "product_res_number": "Z-0815-04", "event_date_initiated": "2004-03-25", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2005-11-23", "res_event_number": "28638", "product_code": "DTZ", "k_numbers": [ "K936003", "K973760" ], "product_description": "Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R", "code_info": "Lot 0402000017", "firm_fei_number": "1000116158", "recalling_firm": "Medtronic Perfusion Systems", "address_1": "7611 Northland Dr N", "city": "Brooklyn Park", "state": "MN", "postal_code": "55428-1088", "additional_info_contact": "Preeti Jain\n763-391-9533", "reason_for_recall": "An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.", "root_cause_description": "Other", "action": "A notification letter, sent on March 25, 2004, requested that consignees complete and return an enclosed certificate which gives the consignee the option of keeping the product or returning it to the firm.", "product_quantity": "132 units", "distribution_pattern": "The product was shipped to consignees in Florida, Iowa, Louisiana, Maine, Minnesota and New York in the United States.", "openfda": { "k_number": [ "K831122", "K242503", "K990103", "K861641", "K894970", "K223161", "K910107", "K241352", "K912655", "K790356", "K022115", "K140177", "K961530", "K863249", "K872133", "K802328", "K810470", "K811004", "K843955", "K772237", "K102464", "K974085", "K862918", "K191444", "K802719", "K202510", "K103191", "K925626", "K823125", "K802720", 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