{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 308 } }, "results": [ { "cfres_id": "188744", "product_res_number": "Z-0002-2022", "event_date_initiated": "2021-07-27", "event_date_created": "2021-10-01", "recall_status": "Open, Classified", "res_event_number": "88473", "product_code": "FMI", "k_numbers": [ "K930217" ], "product_description": "REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796", "code_info": "Lot/Serial Number - Exp. 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"firm_fei_number": "2020394", "recalling_firm": "Bard Peripheral Vascular Inc", "address_1": "1625 W 3rd St Bldg 1 1625 W 3rd St", "address_2": "Bldg 1", "city": "Tempe", "state": "AZ", "postal_code": "85281-2438", "additional_info_contact": "North American Regional Complaint Center\n1844-823-5433", "reason_for_recall": "Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.", "root_cause_description": "Packaging change control", "action": "On August 4, 2021, Bard Peripheral Vascular, Inc. issued an \"Urgent Medical device Correction\" notice to affected customers via Fed Ex. In addition to informing consignees about the recall product, BD ask consignees to take the following actions: \n\n1. Please check all inventory locations within your institution for the product listed in Attachment A and immediately destroy all affected product remaining in your possession. The product should have the sterile barrier broken and destroyed per your local facility s destruction process.\n\n2. Share this notice with any users of the product within your facilities to ensure they are also aware of this Urgent Medical Device Correction.\n\n3. If you purchased this product from a distributor, contact your distributor for further\ninstructions.\n\n4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process your credit.\n\n5. Please contact your BD representative to assist in this process or you may also contact the number below for further assistance.\n\n6. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program:\nWeb: MedWatch website at www.fda.gov/medwatch\nPhone: 1-800-FDA-1088 (1-800-332-1088)\nMail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787\n\n7. BD Contact Information: If you require further assistance please contact:\n\nNorth American Regional Complaint Center, 1-844-8BD- LIFE (1-844-823-5433)\nSay Recall when prompted, M-F 8am - 5pm CT, Recall Questions, Product\nComplaints, Technical Questions", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WV and the countries of Netherlands, United Arab Emirates, Australia, Taiwan, Asia, South Africa, Canada, JAPAN, India, Hong Kong, New Zealand, Mexico, China, Belgium, Malaysia, Singapore, Vietnam.", "openfda": { "k_number": [ "K934088", "K012646", "K123684", "K943575", "K933674", "K102774", "K161255", "K920717", "K073257", "K032885", "K874602", "K131358", "K171982", "K970370", "K935777", "K961088", "K062608", "K842542", "K832556", "K862610", "K040531", "K922179", "K823696", "K252908", 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