{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "43331",
      "product_res_number": "Z-0357-06",
      "event_date_initiated": "2005-12-13",
      "event_date_posted": "2006-01-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-05-15",
      "res_event_number": "34198",
      "product_code": "FAP",
      "product_description": "Schuster Anorectal Manometry Probe.  Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-5050.  *** Size: Pediatric... CAUTION:  Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.'  Additional labeling found on the pouch reads in part: 'Labeling for the device reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Distributed by: Cardinal Health McGaw Park, IL ***'.",
      "code_info": "Product model # A86-5050.   All lot numbers.",
      "firm_fei_number": "2023374",
      "recalling_firm": "Sandhill Scientific, Inc",
      "address_1": "9150 Commerce Center Cir Ste 500 9150 Commerce Center Cir",
      "address_2": "Ste 500",
      "city": "Highlands Ranch",
      "state": "CO",
      "postal_code": "80129-1563",
      "additional_info_contact": "Guy Harris\n303-470-7020",
      "reason_for_recall": "The product is mislabeled.  The labeling on the front of the packaging states that product contains latex.  However, the back of the package contains a latex- free symbol.",
      "root_cause_description": "Other",
      "action": "Consignees were notified by letter on 12/13/2005.",
      "product_quantity": "4342 probes total for both sizes.",
      "distribution_pattern": "CA, CO, GA, KS, LA, IN, IL, ID, IA, MD, MO, NE, NJ, NM, OR, PA, TN, TX, VA, VT, WA, WV. Military hospitals in CA and CO. Foreign distribution to Egypt, Netherlands.",
      "openfda": {
        "k_number": [
          "K923995",
          "K792091",
          "K913736",
          "K792090",
          "K910444",
          "K974775",
          "K920451",
          "K770579",
          "K920575",
          "K922476",
          "K924383",
          "K913169",
          "K850696",
          "K834503",
          "K812178",
          "K914300",
          "K921047",
          "K963330",
          "K863168",
          "K902692",
          "K874758",
          "K853059",
          "K852856",
          "K792093",
          "K800822",
          "K902843",
          "K860571",
          "K113771",
          "K823561",
          "K911091",
          "K850693",
          "K844503",
          "K910371",
          "K912701",
          "K881736",
          "K920991",
          "K853683",
          "K863165",
          "K931179",
          "K874759",
          "K920992",
          "K790519",
          "K920777",
          "K851483",
          "K870855",
          "K792094",
          "K790478",
          "K792092",
          "K896575",
          "K863167",
          "K833628",
          "K850694",
          "K853936",
          "K862327",
          "K863169",
          "K910217",
          "K790754",
          "K820144",
          "K901494",
          "K931175",
          "K850601",
          "K904646",
          "K915484",
          "K962472",
          "K822916",
          "K821939",
          "K823432",
          "K850695",
          "K914891",
          "K802374",
          "K924086",
          "K915443",
          "K850602",
          "K900494",
          "K913323",
          "K863312",
          "K904386",
          "K910285",
          "K911125",
          "K923464",
          "K884915",
          "K912451",
          "K842124",
          "K884920",
          "K771850"
        ],
        "device_name": "Cystometric Gas (Carbon-Dioxide) On Hydraulic Device",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1620",
        "device_class": "2",
        "registration_number": [
          "3000296634",
          "3004365956",
          "3011137372",
          "3006849754",
          "1930870",
          "2132111",
          "1820334",
          "3011534533",
          "1825146"
        ],
        "fei_number": [
          "3000296634",
          "3004365956",
          "3006849754",
          "1930870",
          "1820334",
          "1000140026",
          "3005747797",
          "3011534533",
          "1825146"
        ]
      }
    }
  ]
}