{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217364", "product_res_number": "Z-0897-2026", "event_date_initiated": "2025-11-12", "event_date_posted": "2025-12-11", "recall_status": "Open, Classified", "res_event_number": "97976", "product_code": "FYA", "k_numbers": [ "K193327" ], "product_description": "ChemoPlus gowns:\nProduct Code\tProduct Description\nCT5500T\tChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile;\nCT5502T\tChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile;\nCT5503T\tChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue,\nNon-sterile;\nCT5504T\tChemoPlus Full Coverage Gown,\nClosed Back, Extra Large, Medium Blue, Non-sterile;\nCT5505T\tChemoPlus Full Coverage Gown,\nClosed Back, Extra Extra Large, Medium Blue, Non-sterile;\nDP5001GT\tChemoPlus Full Coverage Gown,\nOpen Back, Large, medium Blue, Non- sterile;\nDP5002GT\tChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue,\nNon-sterile;\nDP5003GT\tChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue,\nNon-sterile;\nDP5004GT\tChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile;\nCT5500TS\tChemoPlus Full Coverage Sleeve,\nUniversal, Medium Blue, Sterile;\nCT5502TS\tChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium\nBlue, Non-sterile;\nCT5503TS\tChemoPlus Full Coverage Gown,\nClosed Back, Large, Medium Blue, Sterile;\nCT5504TS\tChemoPlus Full Coverage Gown,\nClosed Back, Extra Large, Medium Blue, Sterile;\nCT5505TS\tChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large,\nMedium Blue, Sterile;", "code_info": "Product Code\tLot #\tUDI-DI (GTIN):\n\nCT5500T\tALL LOT NUMBERS LESS THAN OR EQUAL TO\n22GASN045\tCS- 50885380172371 EA- 20885380172370;\n\nCT5502T\tALL LOT NUMBERS LESS THAN OR EQUAL TO 22GASN044\tCS 50885380172395\nEA - 20885380172394;\n\nCT5503T\tALL LOT NUMBERS LESS THAN OR EQUAL TO\n22GASN036\tCS 50885380172418\nEA - 20885380172417;\n\nCT5504T\tALL LOT NUMBERS LESS\nTHAN OR EQUAL TO 22EASN004\tCS- 50885380172432\nEA- 20885380172431;\n\nCT5505T\tALL LOT NUMBERS LESS\nTHAN OR EQUAL TO 22GASN043\tCS- 50885380172456\nEA- 20885380172455;\n\nDP5001GT\tALL LOT NUMBERS LESS\nTHAN OR EQUAL TO 22GASN033\tCS- 50885380173989 EA-20885380173988;\n\nDP5002GT\tALL LOT NUMBERS LESS THAN OR EQUAL TO\n22EASN020\tCS- 50885380173996 EA-20885380173995;\n\nDP5003GT\tALL LOT NUMBERS LESS THAN OR EQUAL TO\n22GASN020\tCS- 50885380173972 EA-20885380173971;\n\nDP5004GT\tALL LOT NUMBERS LESS THAN OR EQUAL TO 22BASN087\tCS- 50885380174009 EA-20885380174008;\n\nCT5500TS\t21KAS095\tCS- 50885380172388\nEA-20885380172387;\n\nCT5502TS\t21KAS059\tCS- 50885380172401 EA-10885380172403;\n\nCT5503TS\t21KAS106, 21LAS004,\n21LAS017\tCS- 50885380172425 EA-10885380172427;\n\nCT5504TS\t21KAS064, 21KAS072,\n21KAS109\tCS- 50885380172449 EA-10885380172441;\n\nCT5505TS\t21KAS019, 21KAS031\tCS- 50885380172463 EA-10885380172465;", "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\n888-444-5440", "reason_for_recall": "Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.", "root_cause_description": "Under Investigation by firm", "action": "On November 12, 2025, firm began notifying customers via Urgent Medical Device Product Recall letters. Customers were instructed to segregate and quarantine all affected product upon review of inventory. All affected product should be returned to the firm.\n\nCustomers who have further distributed affected product should notify any customers impacted by this recall.", "product_quantity": "251,165 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Canada.", "openfda": { "k_number": [ "K931144", "K132386", "K791062", "K012186", "K203237", "K920996", "K121152", "K172445", "K931456", "K914235", "K211399", "K080707", "K213844", "K882470", "K760864", "K163191", "K990395", "K202447", "K220665", "K203548", "K921154", "K233571", "K253003", "K221559", "K102652", "K221977", "K834332", "K210143", "K043585", "K921152", "K080627", "K932694", "K923815", "K031933", "K930681", "K001189", "K202706", "K914563", "K981393", "K802885", "K213177", "K150151", "K090383", "K141095", "K252575", "K922949", "K970893", "K792622", "K192362", "K052824", "K934608", "K214108", "K934664", "K212861", "K971920", "K150598", "K041539", "K093169", "K222480", "K992514", "K842958", 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"3013525704", "3012344767", "3010131137", "3005142514", "1423537", "1123137", "3013502418", "3014159736", "1836161", "3019798849", "3008328679", "3036773433", "3015633688", "3017467279", "3015140351", "3006425876", "2030624", "3001650535", "8030607", "3004133257", "3010625818", "3013421458", "3016452400", "3010873451", "3023228837", "2183744", "1058584", "3004122598", "1043644", "3014925389", "1054241", "2320762", "3032507796", "3010154727", "3015068387", "3015468759", "3013735189", "3014479313", "3003348807", "1423395", "3009750712", "3042953920", "3004713352", "1047429", "3021274073", "1643817", "1527185", "3014926389", "3015173212", "1818910" ], "fei_number": [ "3005595283", "3044906632", "3013429557", "3003792528", "3015895045", "3030419987", "2523865", "3030446844", "3008191254", "3005997949", "3014146451", "3001124136", "3031572397", "3011547453", "1527607", "3011500469", "3012421607", "3016096096", "1000346129", "3000210101", "1018470", "3007007790", "3034629649", "3043226252", 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"3016509375", "3007344957", "3003094575", "3010621964", "3016711507", "3012268821", "3003561450", "3013525704", "3012344767", "3010131137", "3003058448", "3006003617", "3006509795", "3005142514", "3013502418", "3014159736", "3019798849", "3008328679", "3036773433", "3015633688", "3017467279", "3194", "3015140351", "3006425876", "3001650535", "3000206435", "3004133257", "3010625818", "3013421458", "3016452400", "3010873451", "3023228837", "2183744", "3004122598", "3014925389", "1043644", "3008439903", "3032507796", "3002902735", "3010154727", "3015068387", "3015468759", "3003154916", "3013735189", "3014479313", "3003348807", "3000717925", "3008373372", "1000582923", "3009750712", "3042953920", "3004713352", "1047429", "3021274073", "1643817", "1527185", "3014926389", "3015173212", "1818910" ], "device_name": "Gown, Surgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4040", "device_class": "2" } } ] }