{ "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": "38827", "product_res_number": "Z-0905-05", "event_date_initiated": "2005-05-05", "event_date_posted": "2005-06-17", "recall_status": "Terminated", "event_date_terminated": "2008-09-02", "res_event_number": "31966", "product_code": "FMK", "product_description": "Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth, stock code 5000052, packaged in single unit blister packs, 200 per box, 6 boxes per carton, stock code 5000101, packaged in single unit blue cap packaging, 100 per box, and stock code 5000115, packaged in single unit blue cap packaging, 200 per box; Virotek, L.L.C., 900 Asbury Dr., Buffalo Grove, IL 60089", "code_info": "stock code 5000052, 5000101and 5000115, lot numbers 0018, 0023, 0024, 0025, 0026, 0027, 0028", "firm_fei_number": "3002689104", "recalling_firm": "Efoora, Inc. dba Virotek, L.L.C.", "address_1": "900 Asbury Dr", "city": "Buffalo Grove", "state": "IL", "postal_code": "60089-4557", "additional_info_contact": "Ms. Mary Hill\n847-634-4500 Ext. 277", "reason_for_recall": "The sterility of the lancets may be compromised due to inadequate packaging seals.", "root_cause_description": "Other", "action": "Efoora/Virotek sent recall notifications to their customers via fax and DHL delivery on 5/5/05 through 5/27/05. The accounts were informed that the sterility of the lancets had been compromised due to inadequate seals. The accounts were requested to check their inventories for the affected lots, discontinue their use/distribution, and return the product to Efoora for a refund. Any questions were directed to Mary Hill, Director of Quality Assurance at 847-634-4500, ext. 277.", "product_quantity": "763,500 units", "distribution_pattern": "Nationwide and internationally to Australia, Belgium, Bolivia, Colombia, Finland, Israel, Italy, Japan, Mexico, Nigeria, Russia, Singapore, South Africa, Spain, Sweden, Taiwan, Trinidad, United Kingdom and Zimbabwe.", "openfda": { "k_number": [ "K232509", "K222055", "K193009", "K911997", "K244036", "K222168", "K222376", "K232488", "K823760", "K251694", "K220917", "K223208", "K863621", "K241750", "K221521", "K130132", "K242627", "K222224", "K242664", "K865016", "K820333", "K192666", "K223201", "K923302", "K833812", "K861265", "K222090", "K041665", "K223313", "K243533", "K942620", "K252490", "K222408", "K841677", "K870017", "K101145", "K222303", "K833816", "K833344", "K240806", "K221126", "K101417", "K221783", "K820625", "K942548", "K220643", "K261045", "K242316", "K931258", "K854760", "K850100", "K861243", "K883420", 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"3007382160", "3010194621", "3011191255", "3002808145", "3003348846" ], "device_name": "Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4850", "device_class": "2" } } ] }