{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "cfres_id": "38462",
      "product_res_number": "Z-0842-05",
      "event_date_initiated": "2005-03-18",
      "event_date_posted": "2005-05-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-11-22",
      "res_event_number": "31765",
      "product_code": "DXE",
      "k_numbers": [
        "K011056"
      ],
      "product_description": "The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes:  PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath.  The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistulas.  The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires) that rotates at 3000 rpm when rotator is activated.  The current device is 7 Fr in size and comes in two lengths -- 65 cm and 120 cm.  This device is used by inserting the catheter into the occluded graft or fistula via introducer sheath and then activating the rotator unit.",
      "code_info": "All units with Lot Numbers beginning with: MF311; MF312; MF401; MF402; MF403; MF404; MF405; MF406; MF407; MF408; MF409; MF410; MF411; MF412; MF501.",
      "firm_fei_number": "3015859709",
      "recalling_firm": "Arrow International Inc",
      "address_1": "2400 Bernville Rd",
      "city": "Reading",
      "state": "PA",
      "postal_code": "19605-9607",
      "additional_info_contact": "Terrance Larkin\n610-378-0131 Ext. 8535",
      "reason_for_recall": "The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use.",
      "root_cause_description": "Other",
      "action": "The firm began notification of consignees on 3/23/2005 via certified letter.",
      "product_quantity": "2418 UNITS",
      "distribution_pattern": "Product was distributed nationwide to dealers, hospitals, sales representatives, and subsidiaries (distributors).  The product was also distributed to Australia, Canada, Colombia, Czech Republic, France, Germany, Israel, Italy, Japan, Netherlands, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom.   There are no government accounts.",
      "openfda": {
        "k_number": [
          "K832023",
          "K883852",
          "K971314",
          "K780762",
          "K992940",
          "K920871",
          "K961716",
          "K100840",
          "K163353",
          "K790838",
          "K950586",
          "K901627",
          "K864007",
          "K973477",
          "K970762",
          "K213771",
          "K233820",
          "K761031",
          "K832044",
          "K864330",
          "K901625",
          "K901502",
          "K972572",
          "K233619",
          "K780244",
          "K961992",
          "K850015",
          "K992933",
          "K152335",
          "K961883",
          "K891021",
          "K954760",
          "K193379",
          "K163031",
          "K982141",
          "K974335",
          "K840198",
          "K820646",
          "K905139",
          "K935405",
          "K801650",
          "K897184",
          "K902327",
          "K973465",
          "K894681",
          "K241330",
          "K910372",
          "K011783",
          "K992934",
          "K893680",
          "K233819",
          "K864062",
          "K853625",
          "K955125",
          "K002627",
          "K202049",
          "K970657",
          "K892410",
          "K992368",
          "K972623",
          "K972511",
          "K020634",
          "K240078",
          "K081573",
          "K881455",
          "K914880",
          "K872485",
          "K812640",
          "K770714",
          "K770569",
          "K100842",
          "K920823",
          "K022145",
          "K900311"
        ],
        "registration_number": [
          "3015859709",
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          "3009051888",
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          "3006082230",
          "1721504",
          "2027111",
          "3008496528",
          "2183744",
          "3012050423",
          "1319639",
          "1220452",
          "8043983",
          "9680794",
          "3010041511",
          "3011137372",
          "9617465",
          "1061124",
          "3013666218",
          "1000393132",
          "3005704822",
          "1820334",
          "2015691",
          "3035111606",
          "2183870",
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        ],
        "fei_number": [
          "3015859709",
          "",
          "1000306647",
          "3003769549",
          "1000138054",
          "3009051888",
          "3005747797",
          "1018233",
          "2024311",
          "1721686",
          "1220948",
          "3045042524",
          "2648045",
          "3003081151",
          "2522007",
          "3032916632",
          "3006082230",
          "1721504",
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          "3003737899",
          "1000512168",
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          "3005704822",
          "1820334",
          "2015691",
          "3035111606",
          "2183870",
          "3030714660"
        ],
        "device_name": "Catheter, Embolectomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5150",
        "device_class": "2"
      }
    }
  ]
}