{ "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": "103146", "product_res_number": "Z-0142-2012", "event_date_initiated": "2011-09-23", "event_date_posted": "2011-10-31", "recall_status": "Terminated", "event_date_terminated": "2013-04-11", "res_event_number": "59582", "product_code": "DRY", "k_numbers": [ "K972962" ], "product_description": "CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. \nCatalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. \nCatalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and \nCatalog 500A, CDI 500 Monitor with Arterial blood parameter module.\n\nIntended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.", "code_info": "Catalog # 500AVHCT, CDI Blood Parameter Monitoring Systerm 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe; serial numbers 1038,1217,1381,1459,1461, 2515, 3022, 3446, 4043, 4260, 5048-5056, 5065-5077, 5082-5085,5094-5101,5118-5125,5142-5149,5158-5169, 5178, 5179, 5190,5197,5198, 5210-5213,5222-5225,5238-5245, 5250-5253,5274-5277, 5282-5285, 5290-5293, 5298-5305, 5318-5321, 5334-5337, 5341-5344,5354-5356,5370-5374, 5383, 5385, 5386, 5516-5521, and 5537-5541.  Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Serial numbers 1258, 1361, 1518, 1571, 1636, 1690,1717,1775,1875,1882, 2026,2292,2413,2459,2832, 2984,3092,3256,3313,3432, 3527, 3633, 3660, 3790, 3825, 4104, 5040-5047, 5057-5064, 5078-5081,5086-5093,5102-5117, 5126-5141, 5150-5157, 5170-5177,5180-5189,5191-5196, 5199-5209,5214-5221, 5226-5237, 5246-5249, 5254-5273, 5278-5281,5286-5289, 5294-5297,5306-5317,5322- 5329, 5345-5348, 5350-5353, 5358-5369, 5375-5382, 5387, 5388, 5500-5515, 5527-5529, 5531,5542,5543,and 5546-5556  Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules. Serial numbers 0033, 0051, 1465, 5330, 5331, 5332, 5333, 5338, 5339, and 5340.  Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Serial numbers 1560 and 5349.", "firm_fei_number": "1828100", "recalling_firm": "Terumo Cardiovascular Systems Corporation", "address_1": "6200 Jackson Road", "city": "Ann Arbor", "state": "MI", "postal_code": "48103-9586", "additional_info_contact": "800-521-2818", "reason_for_recall": "Terumo CVS identified a defective circuit board, which could potentially cause the CDI monitor to not function after a power loss. Once power is lost, the monitor will not power up again, even if AC or battery power are restored.", "root_cause_description": "Component design/selection", "action": "Terumo Cardiovascular Systems Corporation sent an \"URGENT MEDICAL DEVICE CORRECTION\" notice dated September 23, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides information on what to do in the event of a failure of the device. Additionally, a Customer Response Form was attached to the letter for customers to complete and return. Terumo CVS will schedule the return of affected products for inspection and replacement of defective parts. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this notice.", "product_quantity": "432", "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of Canada, Chile, Japan, Philippines, and Thailand.", "openfda": { "k_number": [ "K072131", "K090147", "K915255", "K900682", "K881006", "K910421", "K234065", "K123039", "K861277", "K811391", "K071725", "K900459", "K931968", "K941922", "K181923", "K955380", "K163657", "K182110", "K133157", "K973472", "K012743", "K862069", "K823359", "K854357", "K852124", "K202557", "K062468", "K821159", "K915265", "K110957", "K001388", "K202154", "K862953", "K173591", "K955379", "K903729", "K874839", "K980732", "K871221", "K133658", "K871686", "K091908", "K843709", "K843538", "K103168", "K972962", "K831225" ], "registration_number": [ "9611109", "2029275", "1828100", "3044156918", "2011171", "3011560054", "1218950", "1124841", "2184009", "1319639", "3016618143", "3019807891", "3002807090", "3000126629", "1928237", "1118880", "3006073153", "3002807561", "2245590", "9680841", "9617601" ], "fei_number": [ "1828100", "3002534070", "1000138054", "3005426550", "3044156918", "2011171", "3011560054", "1218950", "1000306431", "3016618143", "3002808267", "3019807891", "3000126629", "1928237", "1118880", "1000116158", "3006073153", "3000204839", "3002807561", "3006003617", "2245590" ], "device_name": "Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4330", "device_class": "2" } } ] }