{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196186", "product_res_number": "Z-0122-2023", "event_date_initiated": "2022-09-09", "event_date_posted": "2022-10-21", "recall_status": "Open, Classified", "res_event_number": "90911", "product_code": "LRO", "product_description": "MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592", "code_info": "UDI/DI (01)40193489497220 (case), (01)10193489497229 (kit), Lot Numbers: 22GME974, 22FMF309", "firm_fei_number": "1417592", "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Karin Johnson\n886-359-1704", "reason_for_recall": "Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.", "root_cause_description": "Process control", "action": "Medline disseminated a recall notice titled \"IMMEDIATE ACTION REQUIRED\" by US mail and email on 09/16/2022and 09/23/2022. The notice requested the following:\n\n\"REQUIRED ACTION: \n1.\tImmediately check your stock for Kit Number and Kit Lot Number, listed on the destruction form, quarantine all affected product. Destroy all product belonging to the affected lot numbers listed on the destruction form. \n\n2.\tPlease return the completed enclosed destruction form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. \n\nWhen we receive your completed destruction form your account will be issued a credit, if applicable.\n\n3.\tIf you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. \n\nIf you have any questions, please contact 866-359-1704.\"", "product_quantity": "1600 kits", "distribution_pattern": "US Nationwide distribution in the state of California.", "openfda": { "k_number": [ "K212258", "K934028", "K951149", "K894685", "K871873", "K963721", "K883250", "K890098", "K932217", "K881083", "K945160", "K962826", "K933137", "K920292", "K965201", "K884093", "K873973", "K923600", "K936117", "K910368", "K854292", "K934428", "K971062", "K871459", "K953083", "K041080", "K931759", "K874760", "K971061", "K890729", "K880961", 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