{ "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": "190017", "product_res_number": "Z-0318-2022", "event_date_initiated": "2021-11-02", "event_date_created": "2021-12-01", "recall_status": "Terminated", "event_date_terminated": "2023-05-08", "res_event_number": "88919", "product_code": "JKA", "k_numbers": [ "K192247" ], "product_description": "The Steripath Gen2 Blood Collection System\n\nModel Number/Description\n2700-21-EN\t/ Steripath Gen2 Blood Collection System - 21G, Wide Neck\n2700-23-EN\t/ Steripath Gen2 Blood Collection System - 23G, Wide Neck\n27BD-21-EN\t/ Steripath Gen2 Blood Collection System - 21G, Long Neck\n27BD-23-EN\t/ Steripath Gen2 Blood Collection System - 23G, Long Neck", "code_info": "Model Number/Part Number/Description:\n2700-21-EN/P00157-001/Steripath Gen2 Blood Collection System - 21G, Wide Neck\nUDI Sales Pack: 10858366007013\nUDI Sterile Pack: 00858366007016\nLot Numbers:\n9447412\n9447043\n9446903\n9447120\n9446991\n9447413\n\n2700-23-EN/P00158-001/Steripath Gen2 Blood Collection System - 23G, Wide Neck\nUDI Sales Pack: 10858366007020\nUDI Sterile Pack: 00858366007023\nLot Numbers:\n9446807\n9447124\n5005432\n9446708\n9447121\n\n27BD-21-EN/P00166-000/Steripath Gen2 Blood Collection System - 21G, Long Neck\nUDI Sales Pack: 10858366007037\nUDI Sterile Pack: 00858366007030\nLot Numbers:\n5005328\n9446696\n9446547\n9446994\n\n27BD-23-EN/P00167-000/Steripath Gen2 Blood Collection System - 23G, Long Neck\nUDI Sales Pack: 10858366007044\nUDI Sterile Pack: 00858366007047\nLot Numbers:\n9447122", "firm_fei_number": "3009976527", "recalling_firm": "Magnolia Medical Technologies, Inc.", "address_1": "200 W Mercer St Ste 500 200 W Mercer St", "address_2": "Ste 500", "city": "Seattle", "state": "WA", "postal_code": "98119-5908", "additional_info_contact": "Kristine Dela Vega\n415-969-8183", "reason_for_recall": "Due to an uptick of complaints associated with premature needle retraction of blood collection system.", "root_cause_description": "Process control", "action": "On 11/02/2021, the Recalling Firm sent an \"URGENT: MEDICAL DEVICE RECALL\" Notification Letter to customers via email informing them that the firm has received a number of product complaints associated with its blood collecting systems where the retractable feature of the butterfly needles may prematurely activate. The product complaints have been associated with retractable feature being activated within the product packaging.\n\nCustomers are instructed to:\n-Determine the quantity of the affected products remaining at their facility and communicated this to the Recalling Firm's Sales or Clinical team members.\n-The Recalling Firm will replace any of the affected products at no cost to the customer.\n-Notify all their staff of the recall and if the affected products have been further distributed, to contact/notify those customers/organization of this recall.", "product_quantity": "137,200 devices", "distribution_pattern": "U.S. Nationwide distribution in the states of MD, WV, DE, VA, DC, IN, MI, MA, SC, NY, IL, TX, AL, OK, GA, NE, FL, MO, CA, CO, NM, AR, WY, KS, PA, WA, MT, and AZ.", "openfda": { "k_number": [ "K884807", "K193569", "K022130", "K945952", "K790485", "K252899", "K981013", "K252040", "K950432", "K991551", "K883813", "K965202", "K250907", "K792723", "K830472", "K193074", "K220212", 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