{ "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": "84750", "product_res_number": "Z-0141-2010", "event_date_initiated": "2009-08-28", "event_date_posted": "2009-11-09", "recall_status": "Terminated", "event_date_terminated": "2010-05-12", "res_event_number": "53137", "product_code": "FCG", "product_description": "Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8\" (13.7 cm), catalog #OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog #OS5000", "code_info": "catalog #OS5000-005, lot number K08", "firm_fei_number": "3001236905", "recalling_firm": "Cardinal Health", "address_1": "1430 Waukegan Rd Mc Gaw", "city": "Park", "state": "IL", "postal_code": "60085-6726", "additional_info_contact": "Michele B. Donatich R.N.\n847-473-1500", "reason_for_recall": "The Craig Calibrated Cannula does not interface with the toothed cutter properly, which may prevent the toothed cutter from properly advancing through the cannula to the biopsy site.", "root_cause_description": "Nonconforming Material/Component", "action": "Cardinal Health sent Urgent Product Recall letters dated 8/28/09 to all customers who received the product during the recalled period on the same day via UPS Next Day Air. The accounts were informed of the problem with the cannula, and were instructed to functionally test the cannula by passing the toothed cutter within it to ensure the cutter advances freely into the cannula. If any restriction is noticed, the product should be segregated and returned to Cardinal Health. The accounts were requested to complete and return by fax the enclosed acknowledgement form, indicating the number of affected cannulas being returned. Any questions were directed to V. Mueller Customer Service at 800-323-9088.", "product_quantity": "19 units", "distribution_pattern": "Nationwide distribution.", "openfda": { "k_number": [ "K840168", "K181756", "K013069", "K892068", "K951598", "K210476", "K896932", "K103668", "K021847", "K945813", "K961185", "K013070", "K252646", "K131925", "K140137", "K854289", "K062979", "K011075", "K212822", "K962569", "K934256", "K954596", "K915801", "K103694", "K890327", "K230909", "K070179", "K840144", "K212819", "K844993", "K050135", "K141894", "K800420", "K011270", "K073399", "K142688", "K051247", "K181994", "K840354", "K941722", "K924271", "K092359", "K160229", "K935844", "K070129", "K013356", "K171596", "K943304", "K151373", "K083330", "K133763", "K013071", "K160890", "K051506", "K910720", "K002946", "K902320", "K951421", "K024120", "K100712", "K093195", "K180363", "K012864", "K854404", "K013109", "K934356", "K981889", "K133008", "K962905", "K895897", "K983218", "K944944", "K002944", "K091257", "K902319", "K990220", 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