{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "177110", "product_res_number": "Z-0420-2020", "event_date_initiated": "2019-10-22", "event_date_created": "2019-11-18", "recall_status": "Terminated", "event_date_terminated": "2022-06-29", "res_event_number": "84065", "product_code": "DWF", "k_numbers": [ "K123370" ], "product_description": "EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8\") 3/8\" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): \nEZC21A (00690103174182), \nEZC21TA (00690103174199), \nEZC24A (00690103714401), \nEZC24TA (00690103714418),\n EZF21A (00690103175080),\nEZF21TA (00690103175097),\nEZF24A (00690103175066), \nEZF24TA (00690103175073), \nEZS21A (00690103172096),\n EZS21TA (00690103172102), \nEZS24A (00690103172119), \nand EZS24TA (00690103172126)\nProduct Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6 Fr. (2 mm) to 18 Fr. (6 mm) can be used in pediatric patient populations.", "code_info": "Lot #s: 203876 207654 217024 226788,205724, 207655, 217025, 226938,205775, 208823, 217048, 227494,205868, 208893, 218185, 227886,205920, 208894, 218457, 228009,205921, 209901, 218539, 228259,205922, 209904, 219090, 228549,206369, 210110, 219212, 228558,206372, 210111, 219561, 229051,206373, 212032 ,220146 ,229054,206374, 212033 ,220151 ,229827,206768, 212034 ,220157 ,230690,206769, 212035 ,220802 ,230894,206770, 212258 ,220803 ,231105,206771, 212280 ,222841 ,231109,206772, 212959 ,222913 ,231111,206773, 213506 ,222914 ,231291,206774, 213914 ,222915 ,231485,206775, 214214 ,223174 ,232109,206776 ,214216 ,224233 ,232437,206777 ,214716 ,224235 ,234138,206778 ,214717 ,224662,207319 ,214961 ,224707,207320 ,215239 ,225306,207321 ,215495 ,225884,207322 ,216123 ,225885,207323 ,216196 ,226188,207324 ,216627 ,226596,207636 ,216628 ,226597,207638 ,216632, 226691", "firm_fei_number": "2015691", "recalling_firm": "Edwards Lifesciences, LLC", "address_1": "1 Edwards Way", "city": "Irvine", "state": "CA", "postal_code": "92614-5688", "additional_info_contact": "Customer Service\n1800-424-3278 Ext. 1", "reason_for_recall": "Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss.", "root_cause_description": "Under Investigation by firm", "action": "The firm plans to begin mailing a \"urgent - Product Recall\" notification on 10/22/2019 via FedEx Next Day Delivery. All recall notification letters should be mailed by 10/23/2019. The customer notification will request consignees take the following actions:\n\n1. Review this field safety notice to understand the potential hazard, and return all unused\ninventory as instructed.\n\n2. Complete and return the Product Reconciliation Form to Customer Service:\na) Record the quantity of any affected EZ Glide aortic perfusion cannula in your possession,\nb) Segregate and quarantine affected product until returned,\nc) Determine the quantity of EZ Glide aortic perfusion cannula used by subtracting the\nquantity on hand from the quantity shipped to you,\nd) Contact Customer Service to arrange return of affected devices, and\ne) Return affected devices to Edwards with the Return Goods Authorization (RGA) provided.\n\n3. Complete and return the attached Acknowledgement Form within five (5) business days of\nreceiving this notice to Customer Service via fax at (800) 422-9329 or email to\ncs.usfaxes@edwards.com.\n\n4. Distribute this notice within your organization or to any organization where the potentially\naffected devices have been transferred. If you have further distributed this product, notify\nyour customers to the user level. Report any EZ Glide separation to Edwards Lifesciences.\n\n5. The firm reccomends using an alternative device. However if another device is not available the firm provides the following instructions:\n\nShould you elect to use the EZ Glide device in your inventory, we suggest grasping each side of\nthe bond area and applying a firm pull before use to confirm the bond is secure. We also recommend maintaining visibility of the device throughout the procedure. Potential mitigations in the event of cannula separation include ensuring a backup device or 3/8 x 3/8 connector is available.\n\n6. Edwards has communicated this Field Safety Notice to ap", "product_quantity": "62,431 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas,\nKentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Washington DC, Wisconsin, West Virginia, Wyoming and countries of Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Chile, China, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hungary, Canary Islands, Ireland, India, Iceland, Italy, Japan, Mauritius, Malaysia, Netherlands, Norway, Poland, Romania, Sweden, Singapore, Slovakia, Thailand, Turkey, United Arab Emirates, South Africa.", "openfda": { "k_number": [ "K203057", "K971019", "K801359", "K983270", "K061832", "K880779", "K881330", "K881074", "K880103", "K840914", "K042156", "K081820", "K881072", "K831759", "K873212", "K152190", "K884393", "K844139", "K896778", "K130639", "K180453", "K802261", "K000274", "K801770", "K850385", "K953945", "K801401", "K964193", "K890024", "K831332", "K990772", "K203067", "K961270", "K813037", "K781990", "K042984", "K162215", "K111147", "K182586", "K140569", "K002366", "K790565", "K842375", "K031037", "K033463", "K862634", "K971291", "K040173", "K122913", "K001565", "K022042", "K974736", "K792070", "K061254", "K013944", "K253203", "K792202", "K843542", "K801398", "K861310", "K001961", "K792152", "K922471", "K831591", "K052372", "K013013", "K041650", "K801396", "K120780", "K801392", "K924643", "K822210", "K023622", "K851323", "K000776", "K001371", "K180979", 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