{
  "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": "72816",
      "product_res_number": "Z-0166-2009",
      "event_date_initiated": "2007-11-15",
      "event_date_posted": "2008-10-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-12-09",
      "res_event_number": "49128",
      "product_code": "IWJ",
      "product_description": "Alpha-Omega Services, Inc. Product No: NFV0001-004\nDescription: NEEDLE, FLEXIGUIDE: SERIES-15, 25CM, WITH\nFEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG   Quantity: 10/PKG   L-NFV0001-004. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.",
      "code_info": "Lots: F02586, and F02617",
      "firm_fei_number": "2022694",
      "recalling_firm": "Alpha Omega Services Inc",
      "address_1": "9156 Rose Street",
      "city": "Bellflower",
      "state": "CA",
      "postal_code": "90706-6420",
      "additional_info_contact": "562-804-0604",
      "reason_for_recall": "There is a possibility that the Flexiguide Needle tip is defective.  There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Notification of customers initially began November 15, 2007 based \non a cursory visual inspection of the defective needle tips. The initial letter advised that there is a possibility that the Flexiguide Needle tip is defective in that there is the potential for the needle's stylet or an HDR source wire/cable to puncture through the defective needle tip during implant or treatment and penetrate the surrounding tissue thereby injuring the patient and/or breaking the sterile boundary. Further distribution and/or use of these products should not take place. The recall notification was updated on November 27,2007 once results from actual testing were available.  The letter advises that there is a potential for the needle's tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids.  Further distribution and/or use of these products should not take place.  Customers are to return the products for credit. A response form is provided.  Contact Alpha-Omega Services, Inc. at 1-800-346-7894 for assistance.",
      "product_quantity": "29 pkgs (10 each pkg)",
      "distribution_pattern": "NV, AZ, CA, MI, UT, MO, CO, and OH",
      "openfda": {
        "k_number": [
          "K801983",
          "K890485",
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          "K973786",
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          "K904933",
          "K850571",
          "K972554",
          "K940121",
          "K944522",
          "K973184",
          "K980997",
          "K890341",
          "K903403",
          "K010166",
          "K973638",
          "K940550",
          "K973037",
          "K832738",
          "K871213",
          "K813230"
        ],
        "registration_number": [
          "3006017180",
          "2134265",
          "1064858",
          "2020394",
          "1650907",
          "3011106828",
          "1721676",
          "1417485",
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          "3003440305",
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          "2182762",
          "2523676",
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          "3015042204",
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          "3012402886",
          "2184007",
          "1820334",
          "3004111573",
          "9611612",
          "1825146"
        ],
        "fei_number": [
          "3006017180",
          "3002807847",
          "2020394",
          "3011106828",
          "1721676",
          "1417485",
          "1937223",
          "3002095335",
          "3039346136",
          "3003440305",
          "3004982143",
          "1000115748",
          "2182762",
          "2523676",
          "3013070673",
          "3015042204",
          "3002468371",
          "2124215",
          "1625425",
          "3002681132",
          "1037598",
          "3002942387",
          "2025851",
          "1000514656",
          "3003925093",
          "3012690638",
          "1120804",
          "1000064530",
          "1018233",
          "3011545155",
          "3006981798",
          "1000120743",
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          "1219183",
          "3008397795",
          "3012402886",
          "1820334",
          "3004111573",
          "3001092088",
          "1825146"
        ],
        "device_name": "System, Applicator, Radionuclide, Manual",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5650",
        "device_class": "1"
      }
    }
  ]
}