{ "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": "205078", "product_res_number": "Z-0755-2024", "event_date_initiated": "2023-12-21", "event_date_posted": "2024-01-18", "recall_status": "Open, Classified", "res_event_number": "93628", "product_code": "GCX", "product_description": "Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-516", "code_info": "50630140152633 (case), Lot Numbers: J308-606, J308-624, J308-628 J308-642, J308-643, J309-608, J309-610, J309-622, J309-626, J309-633, J309-645, J310-602, J310-617, J310-645", "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": "847-887-5500", "reason_for_recall": "The above-listed lots of Cardinal Health Medi-Vac CRD\" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.", "root_cause_description": "Process control", "action": "Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT CORRECTION notice to its consignees on 12/21/2023 via overnight delivery. The notice explained the issue with the product and requested the consignee post a copy of Attachment A in the storeroom and clinical areas which provides the following information: \nPlease take the following actions: \n\"\"\tInspect liner for misalignment with the outer hard canister during setup. The misalignment can be seen visually during setup as the liner not sitting properly within the canister and can be felt by a springing back of the liner from the outer canister. \no\tReference illustration below\n\"\tTest suction prior to use to ensure the 1L canister liner is working properly on low or low intermittent suction.\n\"\tMonitor intermittent suctioning during use to ensure it is functioning properly. If suction is lost when using the 1L suction canister liner, apply a downward force by adding weight or by pressing down on the canister lid manually to reseal the canister; suction capability should restore.: \nQuestions:\nCONTACT the appropriate Customer Service group with questions related to this notification. Monday Friday between 8:00am - 5pm EST:\n\"\tHospital 800-965-5227\n\"\tFederal Government 800-444-1166\n\"\tDistributor 800-635-6021\n\"\tAll Other Customers 888-444-5440\n\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": "203244 units", "distribution_pattern": "US, Canada, Australia and New Zealand", "openfda": { "k_number": [ "K820765", "K893649", "K042454", "K851384", "K760813", "K893741", "K820337", "K896804", "K892549", "K833674", "K890431", "K902089", "K813066", "K802440", "K881252", "K821841", "K760216", "K912753", "K896558", "K910377", "K952219", "K813394", "K895039", "K821160", "K890129", "K844882", "K844881", "K823037", "K820424", "K911238", "K801979", "K760333", "K951119", "K801942", "K914601", "K894695", "K972074", "K963648", "K781988", "K920912", "K760814", "K896556", 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