{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 28 } }, "results": [ { "cfres_id": "197446", "product_res_number": "Z-0967-2023", "event_date_initiated": "2022-12-14", "event_date_posted": "2023-01-18", "recall_status": "Open, Classified", "res_event_number": "91322", "product_code": "GBX", "product_description": "Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186", "code_info": "UDI/DI 50885380182417(cs), 20885380182416(ea), Lot Numbers: N210278, N210368, N210423, N210460, N210468 , N210469, N210543, N220050, N220099, N220139, N220163", "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": "Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains,\nand broken wound tips.", "root_cause_description": "Unknown/Undetermined by firm", "action": "Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL notice to its consignees on 12/14/2022 by overnight mail. The notice explained the issue, the risk, and requested the following: \nActions Required: \n1. REVIEW your inventory for the affected product codes and lots. Location of product\ncodes and lots are shown above.\n2. SEGREGATE and quarantine all affected product upon review of your inventory. Product should not be used and cease using the product immediately.\n3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product recall notice and share a copy of this\nnotice.\n4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMBFieldCorrectiveAction@cardinalhealth.com, whether you have affected product. \n\nReturn of Product and Available Assistance: \nCONTACT the appropriate Customer Service group to arrange for return and\ncredit/replacement of any affected product Monday 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": "1150 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.", "openfda": { "k_number": [ "K895516", "K942274", "K823496", "K131659", "K951475", "K942335", "K921424", "K840323", "K895757", "K082725", "K965146", "K013417", "K925805", "K913539", "K844922", "K926109", "K955439", "K961295", "K961147", "K973703", "K852143", "K830859", "K950439", "K925748", "K925533", "K922739", "K930551", "K926496", "K770442", "K951907", "K043515", "K843617", "K926495", "K935531", "K052286", "K910245", "K932205", "K932391", "K926408", "K925176", "K933600", "K905766", "K940156", "K955474", "K921934", "K924702", "K905422", "K904133", "K841362", 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