{ "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": "211014", "product_res_number": "Z-0675-2025", "event_date_initiated": "2024-11-01", "event_date_posted": "2024-12-11", "recall_status": "Open, Classified", "res_event_number": "95727", "product_code": "FYC", "k_numbers": [ "K160339" ], "product_description": "Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back, Product Codes AT6588-2XL, AT6588-BD, AT6588-XL, AT6688-2XL, AT6688-BD, and AT6688-XL", "code_info": "All lots.\n\nAT6588-2XL UDI-DI:\nCS (01) 50885380166639\nEA (01) 20885380166638;\n\nAT6588-BD UDI-DI:\nCS (01) 50885380166646\nEA (01) 20885380166645;\n\nAT6588-XL UDI-DI:\nCS (01) 50885380166653\nEA (01) 20885380166652;\n\nAT6688-2XL UDI-DI:\nCS (01) 50885380166660\nEA (01) 20885380166669;\n\nAT6688-BD UDI-DI:\nCS (01) 50885380166677\nEA (01) 20885380166676;\n\nAT6688-XL UDI-DI:\nCS (01) 50885380166684\nEA (01) 20885380166683", "firm_fei_number": "3001236905", "recalling_firm": "Cardinal Health 200, LLC", "address_1": "3651 Birchwood Dr", "city": "Waukegan", "state": "IL", "postal_code": "60085-8337", "reason_for_recall": "Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.", "root_cause_description": "Nonconforming Material/Component", "action": "An URGENT MEDICAL DEVICE PRODUCT RECALL notification letter dated 11/1/24 was sent to customer.\n\nActions Required:\n1. REVIEW your inventory for the affected product codes. Location of product code and is shown on the label below (Attachment 1).\n2. COMMUNICATE with all personnel that utilize the above listed Cardinal Health AAMI Level 3 Isolation Gowns.\n3. SEGREGATE and quarantine all affected product upon review of your inventory. Affected product should not be used. Utilize return directions below to return product.\n4. DISSEMINATE this notice to all departments, clinics and external campuses that handle the affected products.\n5. DISTRIBUTORS please notify any customers to whom you may have distributed/ forwarded affected product to or will send the product on to about this medical device product recall and share a copy of this notice.\n6. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email directly to GMB-FieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not.\n\nReturn of Product and Available Assistance:\nCONTACT the appropriate Customer Service group with questions relating to credit, replacement, and suitable alternative products.\nMonday Friday between 8:00am - 5pm EST:\n\" Hospital 800-964-5227\n\" Federal Government 800-444-1166\n\" Distributor 800-635-6021\n\" All Other Customers 888-444-5440\nFor questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at:\nGMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.", "product_quantity": "940,203 total units", "distribution_pattern": "US Nationwide. Canada, UAE", "openfda": { "k_number": [ "K971917", "K212357", "K223467", "K882281", "K760904", "K851823", "K921058", "K210785", "K923162", "K801162", "K941845", "K952115", "K880484", "K223411", "K930026", "K922442", "K212504", "K221027", "K910410", "K230135", "K971702", "K925077", "K210131", "K801069", "K210414", "K972410", "K982369", "K840229", "K844786", "K952116", "K942351", "K220528", "K212698", "K960999", "K190306", "K211538", "K770488", "K212717", "K212422", "K922234", "K891677", "K952114", "K931145", "K160361", "K210148", "K003749", "K223304", "K954549", "K920404", "K213832", "K954747", "K761080", "K874318", "K160339", "K203415", "K212633", "K232849", "K864479", "K780605", "K171535", "K160471", "K923188", "K874766", "K214116", "K202310", "K945223", "K874888", "K970814" ], "registration_number": [ "3016763307", "3004513970", "9615270", "3015140351", "3014925393", "3008959420", "9680646", "3017896419", "3017597597", "3021274073", "3020755815", "1055236", "3016680688", "3006723155", "3017494520", "3006538071", "3013260641", "1417592", "3026536498", "2648727", "2433012", "3004158259", "3011547453", "3017180923", "3004111573", "3009750712", "3007838093", "3003561450", "3017467279", "1423537", "1043214", "9680222", "3013960812", "3003495693", "1933975", "3012344767", "3009540572", "3013502418", "3016096096", "3015820879", "9611959", "3016705853", "3006400329", "3014421917", "3016678045", "3015960676", "3017171460", "3011545608", "9614306", "1423205", "1018470", "1054241", "2320762", "3010155681", "1921846", "9616096", "3016844398", "9681151" ], "fei_number": [ "3016763307", "3004513970", "3015140351", "3014925393", "3008959420", "3017896419", "3017597597", "3021274073", "3003154916", "3020755815", "1000112877", "3001236905", "3002677549", "3016680688", "3017494520", "3006538071", "3013260641", "1417592", "3003807323", "3026536498", "2648727", "2433012", "3011547453", "3017180923", "3004158259", "3004111573", "3009750712", "3001239227", "3007838093", "3003561450", "3017467279", "3003040625", "1043214", "3013960812", "3003495693", "1000112968", "3012344767", "3009540572", "3013502418", "3015820879", "3016705853", "3006400329", "3001560380", "3014421917", "3016678045", "3015960676", "3017171460", "3003753496", "3011545608", "1018470", "3010155681", "1000582923", "3002750002", "3003792528", "1921846", "3016096096", "3016844398", "3006723155" ], "device_name": "Gown, Isolation, Surgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4040", "device_class": "2" } } ] }