{ "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": "189256", "product_res_number": "Z-0153-2022", "event_date_initiated": "2021-08-24", "event_date_created": "2021-10-19", "recall_status": "Terminated", "event_date_terminated": "2024-12-23", "res_event_number": "88674", "product_code": "KNW", "k_numbers": [ "K171531" ], "product_description": "Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4\"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16\" -1-7/8\") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion.\n\n Original Jamshidi\" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy technique", "code_info": "Cat No.: BEK4511; Lot /Serial No.: 0001379055; UDI # (01)50885403057265(17)211231(10)0001379055;", "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": "Padraic OBrien \n480-597-8203", "reason_for_recall": "Due to misbranded products shipped to customers.", "root_cause_description": "Process control", "action": "On September 15, 2021, the firm, BD, sent out an \"URGENT MEDICAL DEVICE CORRECTION\" letter to their customers and Distributors via FedEx, informing them of the two products, first product or kit had missing component and the second product had extra component of the first product. \n\nThe firm asked customers/Distributors to take the actions as: 1)Please check all inventory locations within your institution for the product listed in Table A and\nimmediately destroy all affected product remaining in your possession. The product should have the sterile barrier broken and destroyed per your local facilitys destruction process.2.) Share this notice with any users of the product within your facilities to ensure they are also aware of this Urgent Medical Device Correction.3.) If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution.4.) Complete and return the attached Customer Response Form to BD Post Market Quality at Email: BDRC20@bd.com or Fax No.: 312-949-0410 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. 5.) Please contact your BD representative to assist in this process or you may also contact the number below for further assistance. 6) Issue credit to customers following receipt of the completed customer response form. 7) Firm initiated actions to prevent recurrence of this product issue. \n\nThe firm asked customers to report any adverse health consequences experienced with the use of this product to the firm and to FDA. \n\nThe firm provided below contact information as : \n\nContact Information: \nNorth American Regional Complaint Center1-844-8BD- LIFE (1-844-823-5433)\nSay Recall when prompted M-F 8am - 5pm CT for Recall Questions, Product Complaints, Technical Questions.", "product_quantity": "360 devices", "distribution_pattern": "U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. \n \nOUS: None", "openfda": { "k_number": [ "K201244", "K982401", "K202012", "K974574", "K033700", "K974794", "K980248", "K052638", "K902066", "K031344", "K102756", 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