{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192339", "product_res_number": "Z-0897-2022", "event_date_initiated": "2022-02-18", "event_date_created": "2022-04-08", "recall_status": "Open, Classified", "res_event_number": "89745", "product_code": "DTQ", "k_numbers": [ "K133598" ], "product_description": "Cardiohelp-i Transport Guard with Transport Guard (701072525):\nis a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours).\n\nProduct Code/REF Number: 701072780 (Cardiohelp-i)", "code_info": "Serial Numbers for the Cardiohelp-i (Part Number 701072780)as the Transport Guard (701072525) is packaged with the Cardiohelp-i and is not labelled individually  Serial Numbers: 90413945, 90414225, 90414226, 90414227, 90414228, 90414229, 90414232, 90414233, 90414234, 90414235, 90414236, 90414237, 90414283, 90414284, 90414285, 90414286, 90414287, 90414288, 90414289, 90414292, 90414293, 90414294, 90414295, 90414296, 90414297, 90414309, 90414310, 90414311, 90414312, 90414317, 90414318, 90414319.  UDI: 04058863074863 (Cardiohelp-i)", "firm_fei_number": "3008355164", "recalling_firm": "Maquet Medical Systems USA", "address_1": "45 Barbour Pond Dr", "city": "Wayne", "state": "NJ", "postal_code": "07470-2094", "additional_info_contact": "SAME\n973-709-7000", "reason_for_recall": "Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.", "root_cause_description": "Process control", "action": "Getinge issued Urgent Medical Device Correction Letter dated 2/18/22 via FedEx 2 day service with signature required. . Letter states reason for recall, health risk and action to take:\nA general decommissioning of the affected Cardiohelp-i is not required, with the consideration of\nthe following:\n1. Please examine your inventory immediately to determine if you have received\nany Cardiohelp-i products with one of the affected serial numbers.\n2. If you have a Cardiohelp-i affected by this field correction, please examine your\ninventory immediately to locate all Transport Guards used with Cardiohelp-i\nproducts. Please ensure that the Transport Guard can be opened and that the\ncylindrical pin is not loose prior to using the device. If so, the device can continue\nto be used.\nIf your Transport guard cannot be opened or if the cylindrical pin is loose,\nplease remove from use and place in a quarantine location to avoid future\nuse.\nThis activity should be performed prior to every use until the field correction activities have been completed at your facility by a Getinge Representative.\n3. Please complete and sign the attached MEDICAL DEVICE CORRECTION -\nRESPONSE FORM (page 5). A Getinge Service Technician will contact the\nperson you list on the Customer Response Form to schedule service for an\ninspection of your device.\nReturn the completed form to Maquet Cardiopulmonary GmbH /Getinge by emailing\na scanned copy to Transportguardpin2022.act@getinge.com or by faxing\nthe form to 1(888) 722-5375.\n If your Transport Guard displays the issue identified in this notification, it\nwill be replaced at no cost to your facility.\n\n4. Whether or not you have affected product(s) with the serial numbers listed in this\nnotice, please complete and sign the attached MEDICAL DEVICE CORRECTION\n- RESPONSE FORM (page 5) to acknowledge that you have received this\nnotification, per the instruction in number 3 above.\n5. You can also arrange a visit by a Getinge trained or au", "product_quantity": "US: 32 units; OUS 30 units", "distribution_pattern": "US Nationwide Distribution: FL, KY, NH, NJ, NY, PA, TX, VA\n\nForeign: Belgium, Canada, Germany, Hungary, Luxemburg, Malaysia, Mexico, Poland, Slovakia, South Africa, South Korea, and Taiwan.", "openfda": { "k_number": [ "K950990", "K964017", "K870976", "K091007", "K131041", "K221373", "K060053", "K021694", "K163531", "K232291", "K092463", "K103762", "K002116", "K822068", "K221895", "K942582", "K030141", "K871131", "K842138", "K190282", "K080832", "K770002", "K173834", "K153376", "K851614", "K172220", "K772001", "K851615", "K915183", "K052555", "K151349", "K133598", "K090006", "K062396", "K011088", "K102726", "K982014", "K861388", "K002118", "K801097", "K093882", "K943803", "K813034", "K022947", "K020571", "K070213", "K210130", "K862973", "K202125", "K863960", "K863541", "K071318" ], "registration_number": [ "3010163695", "3002807090", "1828100", "3011554160", "3042990265", "9680841", "8010762", "9611109", "3007427881", "3005941719", "3006073153", "3010703925", "2916596", "3009507273", "3001589655", "1218444", "3019807891", "2184009" ], "fei_number": [ "3010163695", "1828100", "3011554160", "3042990265", "3002807111", "3005426550", "3007427881", "3006073153", "3006003617", "3010703925", "2916596", "3009507273", "1000116158", "3009649876", "3002808267", "3001589655", "1218444", "3019807891" ], "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4220", "device_class": "2" } } ] }