{ "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": "106336", "product_res_number": "Z-0760-2012", "event_date_initiated": "2011-12-02", "event_date_posted": "2012-01-14", "recall_status": "Terminated", "event_date_terminated": "2012-06-13", "res_event_number": "60737", "product_code": "DTZ", "k_numbers": [ "K014080" ], "product_description": "Apex Oxygenator, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy.\n\nIntended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.", "code_info": "All Lots.", "firm_fei_number": "1718850", "recalling_firm": "Sorin Group USA, Inc.", "address_1": "14401 W 65th Way", "city": "Arvada", "state": "CO", "postal_code": "80004", "additional_info_contact": "Jack Ellison\n303-467-6306", "reason_for_recall": "Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes.", "root_cause_description": "Device Design", "action": "Urgent Field Safety Notices dated December 2, 2011 were sent to customers. The letter identified the affected products and described the problem. The letter also provided additional directions to the Instructions for Use in order to minimize risk and clarify priming procedures. Customers were to communicate the new warning to all personnel in the use of the affected products and complete the Customer Response Form. The form should be returned via fax or e-mail. Questions should be directed towards Sorin Group Customer Service at 1-800-650-2623.", "product_quantity": "19,808 (9,550 stand alone/ 10,258 in packs)", "distribution_pattern": "Worldwide Distribution", "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", "K231414", "K901253", "K050447", "K061628", "K891230", "K932252", "K843956", "K133261", "K810532", "K200683", "K212341", "K964043", "K893704", "K183490", "K872107", "K897068", "K923272", "K833518", "K090450", "K844901", "K882892", "K071494", "K873923", "K772284", "K823273", "K821216", "K841476", "K202206", "K964967", "K092895", "K162016", "K970463", "K810505", "K240934", "K010443", "K172984", "K851035", "K961000", "K122844", "K203111", "K812660", "K073380", "K831894", "K892664", "K030264", "K864235", "K153140", "K962667", "K853251", "K850630", "K222297", "K004001", "K963518", "K191246", "K890808", "K072091", "K803231", "K971877", "K143073", "K991452", "K842908", "K861177", "K101153", "K230640", "K201916", "K853080", "K951247", "K823343", "K760824", "K013480", "K201642", "K901624", "K112360", "K892641", "K926467", "K984271", "K121909", "K033323", "K051997", "K922933", "K781223", "K132829", "K072362", "K013038", "K191029", "K151389", "K874841", "K880021", "K833670", "K153213", "K013915", "K860539", "K231982", "K974812", "K891687", "K140181", "K150489", "K162896", "K962641", "K180950", "K896978", "K040210", "K043323", "K941653", "K151791", "K071774", "K180448", "K903436", "K883054", "K000255", "K933586", "K061031", "K973760", "K893207", "K901250", "K922799", "K093522", "K831895", "K953835", "K130359", "K001021", "K953976", "K912078", "K022450", "K911227", "K153295", "K250821", "K203424", "K800555", "K253838", "K895393", "K960074", "K200109", "K954850", "K031903", "K150267", "K830639", "K100278", "K926226", "K151713", "K102109", "K122827", "K860673", "K140774", "K231652", "K142784", "K240666", "K130520", "K895632", "K992559", "K130280", "K113626", "K896671", "K130209", "K172071", "K083021", "K121536", "K020351", "K062381", "K020997", "K912079", "K010478", "K992910", "K912920", "K823456", "K090511", "K802970", "K090449", "K790406", "K920889", "K912082", "K031223", "K172626", "K894103", "K231773", "K781842", "K190690", "K980974", "K831705", "K090689", "K854045", "K894630", "K830327", "K000430", "K120185", "K863476", "K961734", "K833078", "K183511", "K082117", "K813255", "K014080", "K894826", "K780078", "K803003", "K211495", "K130493", "K925076", "K082403", "K822803", "K934292", "K821477", "K863515", "K991737", "K071572", "K883053", "K141492", "K792039", "K130433", "K901249", "K931444", "K925075", "K941225", "K130333", "K122254", "K080708", "K833253", "K941473", "K121229", "K023381", "K100645", "K123314", "K801240", "K993772" ], "registration_number": [ "9680841", "3015136750", "2011171", "3019807891", "3010155661", "3014990448", "3010163695", "3009507273", "1625519", "1643817", "9617601", "3030125051", "3011554160", "2916596", "1928237", "8010026", "3013267343", "2184009", "1319639", "9681834", "3002807090", "1220648", "3008307705", "3003752502", "3002806603", "1218444", "8010762", "2528981", "3016746283", "3021599320", "3045892899", "1124841", "3005941719", "3044156918" ], "fei_number": [ "1000116158", "1000138054", "3015136750", "2011171", "3019807891", "3010155661", "3014990448", "3000204839", "3010163695", "3009507273", "1625519", "1643817", "3030125051", "3002534070", "2828", "3011554160", "3005426550", "2916596", "1928237", "3013267343", "3009649876", "3002808327", "1220648", "3006003617", "3008307705", "3003752502", "3002806603", "1218444", "2528981", "3016746283", "3021599320", "3045892899", "3002807111", "3044156918" ], "device_name": "Oxygenator, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4350", "device_class": "2" } } ] }