{ "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": "195971", "product_res_number": "Z-0095-2023", "event_date_initiated": "2022-09-15", "event_date_posted": "2022-10-14", "recall_status": "Open, Classified", "res_event_number": "90824", "product_code": "JKA", "product_description": "BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.", "code_info": "UDI-DI:\nCase: 50382903670012;\nShelf: 30382903670018;\nEach: 00382903670017;\n\nALL LOTS are affected.", "firm_fei_number": "2243072", "recalling_firm": "Becton Dickinson & Company", "address_1": "1 Becton Dr", "city": "Franklin Lakes", "state": "NJ", "postal_code": "07417-1815", "additional_info_contact": "North American Regional Complaint Center\n844-823-5433", "reason_for_recall": "The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.", "root_cause_description": "Component design/selection", "action": "On September 15, 2022, the firm notified affected distributors and customers of the recall via Urgent Medical Device Product Advisory letters. Customers were instructed to do the following:\n\n1. Inspect your inventory for the affected catalog number.\n\n2. Ensure the contents of the Product Advisory are read, understood and shared with laboratory management staff having oversight over gas chromatography testing for methanol. Review internal method validations, and if applicable, adjust test practices or settings to avoid potential interference (e.g., implementing the tube as a blank/control, adjustment of GC column and/or operational settings to prevent co-elution, or conversion to dual-column system).\n\n3. If the potential interference cannot be mitigated, stop using the BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg. Product may be returned for credit.\n\nThe recalling firm will update the IFU to address the potential risk of interference from rubber stopper outgassing in gas chromatography methods. The firm has also initiated corrective and preventive action to investigate root cause and identify actions.\n\nIf you have further questions, please contact the firm via \n\nPhone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT\n\nor\n\nEmail: productcomplaints@bd.com", "product_quantity": "2,196,000", "distribution_pattern": "Distribution US nationwide, Canada, New Zealand, and Hong Kong.", "openfda": { "k_number": [ "K884807", "K193569", "K022130", "K945952", "K790485", "K252899", "K981013", "K252040", "K950432", "K991551", "K883813", "K965202", "K250907", "K792723", "K830472", "K193074", "K220212", "K982922", "K212724", "K915814", "K023075", "K012221", "K002456", "K123987", "K921806", "K202446", "K791303", "K040107", "K181895", "K792587", "K081229", "K153309", "K182078", "K213690", "K936240", "K882539", "K980414", "K162233", "K222299", "K802209", "K910646", "K213718", "K201009", "K993787", "K232308", "K864866", "K223810", "K810664", "K901756", 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