{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 8 } }, "results": [ { "cfres_id": "182770", "product_res_number": "Z-2912-2020", "event_date_initiated": "2020-07-29", "event_date_posted": "2020-08-28", "recall_status": "Completed", "res_event_number": "86131", "product_code": "KGO", "k_numbers": [ "K001924" ], "product_description": "PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.", "code_info": "Item Code: 2D72NT55X Lot #: TS19060338, TS19070077, TS19070176, TS19090164, TS19090248, TS19100272, TS19110080, TS20010146, TS20020202, TS20040092  Additional Affected lots as of 10/20/20: TS20040247, TS20050050, TS20050051, TS20050261, TS20060112, TS20060113, TS20070125", "firm_fei_number": "3001236905", "recalling_firm": "Cardinal Health 200, LLC", "address_1": "3651 Birchwood Dr", "city": "Waukegan", "state": "IL", "postal_code": "60085-8337", "additional_info_contact": "Customer Service \n847-689-9101", "reason_for_recall": "A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.", "root_cause_description": "Under Investigation by firm", "action": "Cardinal Health distributed an urgent medical device recall letter dated July 29, 2020 to customers. This letter instructs customers to quarantine all effected product and return the response form to the firm. Product should be returned through the location from which it was purchased.\n\nAn URGENT MEDICAL DEVICE RECALL EXPANSION dated 10/16/20 was sent to customers. The purpose of this notification is to notify that we are expanding the previous action to include additional production lots. Please see Attachment 1 for all affected product codes and lots (new lots in italics). The new product lots were distributed between April 2020 and September 2020.\n\nActions requested on your part:\n1) CHECK all storage and usage locations to confirm whether you have any units of the affected\nproduct codes and lot numbers listed in Attachment 1. Locations of codes are shown in Attachment 2.\n2) SEGREGATE and QUARANTINE all impacted on-hand product.\n3) RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email\n(GMB-FieldCorrectiveAction@cardinalhealth.com) and indicate the product code, lot and quantity of\nproduct youve quarantined or discarded. Please respond regardless of whether or not you have\naffected product.\n4) NOTIFY any customers to whom you may have distributed, or forwarded product affected by this\nrecall. Your notification to your customers may be enhanced by including a copy of this recall\nnotification letter.\n5) CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of\nany affected product Monday Friday between 8:00am - 5:00pm EST:\n\" Hospital800-964-5227\n\" Federal Government800-444-1166\n\" Distributor800-635-6021\n\" All other Customers888-444-5440\n6) CUSTOMERS that did not receive product directly from Cardinal Health should return product through\nthe location where they purchased it.\n\nPlease contact the Customer Service group for any questions related to this action:\n\"", "product_quantity": "7119625 total", "distribution_pattern": "US Nationwide distribution", "openfda": { "k_number": [ "K150146", "K211621", "K222058", "K050181", "K022442", "K984512", "K884499", "K953712", "K962539", "K903513", "K884633", "K951662", "K953358", "K202090", "K943254", "K123628", "K003771", "K973461", "K151778", "K151392", "K913893", "K070619", 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