{ "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": "29916", "product_res_number": "Z-0079-04", "event_date_initiated": "2002-04-23", "event_date_posted": "2003-10-31", "recall_status": "Terminated", "event_date_terminated": "2003-12-04", "res_event_number": "27461", "product_code": "FCG", "k_numbers": [ "K013356" ], "product_description": "EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum Endoscope Channel: 2.0 MM. Disposable-Single Use Only Sterile Shelf Life: 5 Years, Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston Salem, NC 27105.", "code_info": "Lot #1580452, 1583962, 1584813, 1586227, 1587259, 1588313, 1589076, 1590011, 1591358, 1594584 (under hold in finished goods), and 1592359.", "firm_fei_number": "1037905", "recalling_firm": "Wilson-Cook Medical Inc", "address_1": "4900 Bethania Station Rd & 5951 Grassy Creek Blvd.", "city": "Winston-Salem", "state": "NC", "postal_code": "27105", "additional_info_contact": "Jessica Hughes\n336-744-0157", "reason_for_recall": "There is a possibility that the affected devices would not capture a biopsy during a procedure.", "root_cause_description": "Other", "action": "On April 24, 2002 all field representatives were notified via email and all international accounts via fax. Consignees were advised to quarantine all affected product in their possession and to give the product to their Territory Manager for return. Consignees were urged to complete the bottom portion of the letter and return it via the Territory Manager to Wilson-Cook Medical.", "product_quantity": "129 units", "distribution_pattern": "Units were distributed to medical facilities nationwide, UK and Israel", "openfda": { "k_number": [ "K800419", "K962569", "K013069", "K945921", "K771108", "K051506", "K180449", "K954155", "K212423", "K962570", "K050135", "K902319", "K945133", "K950810", "K070129", "K840354", "K013071", "K924271", "K083802", "K895725", "K181756", "K252646", "K896932", "K140137", "K970563", "K180668", "K091257", "K050120", "K103668", "K023272", "K840157", "K854289", "K951598", "K002946", "K081323", "K902320", "K181994", "K070179", "K960317", "K934256", "K892068", "K092359", "K944944", "K971842", "K961897", "K934356", "K926559", "K840168", "K241209", "K890327", "K945146", "K943304", "K151738", "K151373", "K954231", "K160229", "K983218", "K840144", "K800416", "K013109", "K981889", "K935844", "K941563", "K844993", 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