{
  "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": "2026-09-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "222423",
      "product_res_number": "Z-3292-2026",
      "event_date_initiated": "2026-08-10",
      "event_date_posted": "2026-09-25",
      "recall_status": "Open, Classified",
      "res_event_number": "99759",
      "product_code": "FDE",
      "product_description": "Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays\r\n\r\nROBOTIC PACK - 242561\r\nModel No. MHRB88AO",
      "code_info": "UDI-DI 191072236531\t\n\tLots\n42-8513411\n\t42-8580011\n\t42-8663211\n\t42-8775711\n\t42-8801311\n\t42-8840611\n\t42-8865911",
      "firm_fei_number": "3008492337",
      "recalling_firm": "American Contract Systems Inc",
      "address_1": "85 Shaffer Park Dr",
      "city": "Tiffin",
      "state": "OH",
      "postal_code": "44883-9290",
      "additional_info_contact": "Marlene Jones\n419-455-2090",
      "reason_for_recall": "Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).",
      "root_cause_description": "Under Investigation by firm",
      "action": "Firm began notifying affected distributors via email on August 10, 2026. Distributors were instructed to notify end-users.\n\nCustomers were instructed to identify, segregate, and quarantine all impacted products. Customers are to add recall labels to affected kits to ensure the impacted component is discarded prior to use.\n\nAn amended customer letter was sent out on August 28, 2026, which added the following instruction:\n\nUsers should source alternative cleansing wipes for the impacted product lots and ensure they continue to follow their facility protocols for providing perineal care for patients with urinary catheters.",
      "product_quantity": "1,804 kits total",
      "distribution_pattern": "US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.",
      "openfda": {
        "device_name": "Laparoscopy Kit",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "k_number": [
          "K942677",
          "K950924",
          "K955717",
          "K912443"
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