{
  "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": 21
    }
  },
  "results": [
    {
      "cfres_id": "188823",
      "product_res_number": "Z-2521-2021",
      "event_date_initiated": "2021-08-05",
      "event_date_posted": "2021-09-23",
      "recall_status": "Open, Classified",
      "res_event_number": "88499",
      "product_code": "MJC",
      "k_numbers": [
        "K070582"
      ],
      "product_description": "Catalog A119216M, SureStep\" Foley Tray, Lubri-Sil\", Urine Meter, Temperature Sensing Dual, StatLock\" Stabilization Device",
      "code_info": "Catalog A119216M; Lots NGFR2561, UDI (01)00801741073687(17)201228(10)  and NGFS1312, UDI (01)00801741073687(17)201228(10)",
      "firm_fei_number": "1018233",
      "recalling_firm": "C.R. Bard Inc",
      "address_1": "8195 Industrial Blvd NE",
      "city": "Covington",
      "state": "GA",
      "postal_code": "30014-1497",
      "additional_info_contact": "770-784-6100",
      "reason_for_recall": "There is potential for packaging defects that may impact the sterile barrier.",
      "root_cause_description": "Packaging change control",
      "action": "Customer letters were sent \"URGENT MEDICAL DEVICE RECALL\" via FedEx and email to affected consignees on August 13, 2021.  \n\nCustomers are asked to please Take the Following Actions:\n1. Note that there may be a supply disruption in Foley catheter trays from all sources due to the current product shortage driven by this issue and other issues with third party Foley manufacturers.\n2. Please check all inventory locations within your institution for the specific catalog and lot number combinations listed in Attachment 1 of this recall notice.\n3. Share this recall notice with any users of the product, within your facilities, to ensure they are also aware of this recall notice.\n4. If you purchased this product from a distributor, contact your distributor for further instructions. \n5. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the notification, whether or not you have any affected product, so that BD may acknowledge your receipt of this notification and process any applicable order credit.\n6. Report any adverse health consequences experienced with the use of this product to BD at the contact information below. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program\n\nBD will process order credits, including shipping costs, for all customers discontinuing use of and returning product as a result of this notification, following receipt of the completed Customer Response Form.  BD has implemented actions to prevent recurrence of this product issue.\n\nThe firm, BD, sent an updated letter dated October 8, 2021 informing customers of additional affected lot numbers that were distributed between March 2021 through July 23, 2021.",
      "product_quantity": "10,150 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K910318",
          "K993464",
          "K983101",
          "K233094",
          "K000251",
          "K984136",
          "K040658",
          "K033477",
          "K001143",
          "K971627"
        ],
        "device_name": "Catheter, Urological (Antimicrobial) And Accessories",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5130",
        "device_class": "2",
        "registration_number": [
          "2320762",
          "1054241",
          "1043214",
          "9611590",
          "1018233",
          "3027301746",
          "2032098",
          "3006082230",
          "8040607",
          "1055236",
          "3012809732"
        ],
        "fei_number": [
          "1000237915",
          "1043214",
          "3003040625",
          "1000112877",
          "3003058448",
          "1000112968",
          "1018233",
          "3027301746",
          "3002806591",
          "3006082230",
          "3012809732"
        ]
      }
    }
  ]
}