{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "188370", "product_res_number": "Z-2247-2021", "event_date_initiated": "2021-06-23", "event_date_created": "2021-08-12", "recall_status": "Open, Classified", "res_event_number": "88314", "product_code": "KNW", "k_numbers": [ "K171531" ], "product_description": "TJM6008\tJamshidi\" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm;\nTJC3513\tJamshidi\" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm;\nTJM4011\tJamshidi\" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm;\nTJC4011\tJamshidi\" Bone Marrow Biopsy/Aspiration Needle. 11G x 10cm;\nTJM4008\tJamshidi\" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm;\nTJC4008\tJamshidi\" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm;", "code_info": "Catalog Number//UDI: TJM6008/(01)10885403044595(17)241031(10)0001330707; TJC3513/(01)1088540344014(17)241031(10)0001330400; TJM4011/(01)10885403044588(17)241031(10)0001330949; TJC4011/(01)10885403044052(17)241031(10)0001331232; TJM4008/(01)10885403044564(10)0001331230(17)241031; TJC4008/(01)10885403044038(17)241130(10)0001334951;  Serial Numbers: 0001330707; 0001330400; 0001330400; 0001330400; 0001331232; 0001331230; 0001334951;", "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 complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.", "root_cause_description": "Packaging process control", "action": "On 07/15/2021, the firm sent an \"URGENT MEDICAL DEVICE CORRECTION\" Notification via FedEx to customers/distributors informing them that the firm has confirmed a complaint regarding an open packaging seal, breaking the sterile barrier.\n\nCustomers are instructed to:\n1. Please check all inventory locations within their institution for the product listed in Table A and immediately destroy all affected product remaining in their possession. The product should have the sterile barrier broken and destroyed per their local facilitys destruction process.\n2. Share this notice with any users of the product within their facilities to ensure they are also aware of this Urgent Medical Device Correction.\n3. If they purchased this product from a distributor, contact their distributor for further instructions.\n4. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the notification, whether or not they have any affected product, so that the Recalling Firm may acknowledge their receipt of this notification and process your replacement.\n5. Please contact their Recalling Firm's representative to assist in this process or they may also contact the number below for further assistance.\n\nThe Recalling Firm will:\n1. \tIssue replacements for all customers affected by the recall following receipt of the completed Customer Response Form.\n2. \ttaken action to prevent recurrence of this product issue. \n\nFor questions or assistance contact (Recall Questions/Product Complaints/Technical Questions):\nNorth American Regional Complaint Center\n1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted\nM-F 8am - 5pm CT", "product_quantity": "3,961 devices", "distribution_pattern": "U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA\n\nO.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan", "openfda": { "k_number": [ "K950732", "K851798", "K981796", "K012224", "K020848", "K993342", "K093512", "K851839", "K111529", "K033616", "K021137", "K941256", 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