{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191988",
      "product_res_number": "Z-0795-2022",
      "event_date_initiated": "2022-01-20",
      "event_date_created": "2022-03-16",
      "recall_status": "Open, Classified",
      "res_event_number": "89553",
      "product_code": "PWY",
      "product_description": "LUMBAR PUNCTURE TRAY ADULT 18G X 3.5",
      "code_info": "Catalog Number: 4303C\nLot Numbers/UDI (GTIN, DI + PI):\n0001411294\t(01)10885403057021(17)220331(10)0001411294\n0001414259\t(01)10885403057021(17)220331(10)0001414259\n0001414361\t(01)10885403057021(17)220331(10)0001414361\n0001415025\t(01)10885403057021(17)220430(10)0001415025\n0001417547\t(01)10885403057021(17)220430(10)0001417547\n0001422377\t(01)10885403057021(17)220630(10)0001422377\n0001425366\t(01)10885403057021(17)220630(10)0001425366\n0001426588\t(01)10885403057021(17)220630(10)0001426588\n0001428500\t(01)10885403057021(17)220630(10)0001428500\n0001431408\t(01)10885403057021(17)220630(10)0001431408\n0001433267\t(01)10885403057021(17)220831(10)0001433267\n0001433868\t(01)10885403057021(17)220930(10)0001433868",
      "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\n844-823-5433",
      "reason_for_recall": "Due to lumbar puncture tray manometer failure mode of leaking and mating issues.",
      "root_cause_description": "Process control",
      "action": "Between 01/28 and 02/01/2022, the firm sent an \"URGENT MEDICAL DEVICE CORRECTION\" Letter via email and FedEx 2-day mailings to customers informing them that between 07/02 to 12/15/2021 the firm received 59 customer complaints for lumbar puncture tray manometers with reported failure modes of leaking and mating issues.\n\nCustomers are asked to take the following actions:\n1. 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 facility s destruction process.\n2. Share this notification with all users within their facilities to ensure they are also aware of this Urgent Medical Device Correction.\n3. If Customers purchased this product from a distributor, contact their distributor for further instructions and credit resolution.\n4. Complete and return the attached Customer Response Form to the Recalling Firm contact noted on the form confirming acknowledgement of the correction notification, whether or not they have any affected product, so that the Recalling Firm may acknowledge their receipt of this notification and process their credit.\n5. Indicate on the response form the quantity of affected product identified at their facility and confirm that this inventory was destroyed.\n6. Contact their Recalling Firm's representative to assist in this process or they may also contact the listed in the notification for further assistance.\n\nFor further assistance contact:\nNorth American Regional Complaint Center -\n1-844-8BD- LIFE (1-844-823-5433), Say  Recall  when prompted\nM-F 8am - 5pm CT",
      "product_quantity": "8,630 devices",
      "distribution_pattern": "U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.\n\nO.U.S. (foreign) including states: Costa Rica and Hong Kong.",
      "openfda": {
        "device_name": "Lumbar Puncture Tray (Adult & Pediatric)",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5570",
        "device_class": "2",
        "registration_number": [
          "1423537",
          "1018470",
          "9616088",
          "2433012",
          "1422598",
          "1061124",
          "1423507",
          "1061927",
          "3009750712",
          "3007329020",
          "3009888344",
          "3004519921",
          "1643817",
          "1921846",
          "1824619",
          "3004111573"
        ],
        "fei_number": [
          "1000220280",
          "3005846326",
          "1000512168",
          "1018470",
          "1643817",
          "2433012",
          "3000203000",
          "3001236905",
          "3002902735",
          "3009750712",
          "3007329020",
          "3009888344",
          "3008002452",
          "1921846",
          "1824619",
          "3004111573"
        ]
      }
    }
  ]
}