{
  "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,
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  "results": [
    {
      "cfres_id": "96709",
      "product_res_number": "Z-0215-2012",
      "event_date_initiated": "2010-12-22",
      "event_date_posted": "2011-11-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-11-30",
      "res_event_number": "57585",
      "product_code": "OHR",
      "product_description": "Angiotech***HSG Procedure Tray 7Fr***1 - 18ga x 1-1/2\" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2 - Sponge Sticks (6\"); 1 - Sound Dilator; 1 - Autobag; 1 - Lubricating Jelly; 2 - Cotton Tipped Swab (8\"); 1 Extension Tubing (30\"); 2 - 3\"x3\" Sponges (12-Ply); 1 - Vaginal Speculum; 1 - HSG Catheter (7Fr); 1 - Fixed Volume Syringe - 3cc; 1 - CSR Wrap***Catalog Number:  660007000***Sterile - For single patient use.  STERILE EO.   Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.\n\nMEDICAL DEVICE TECHNOLOGIES, INC.  3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, customer_service@angio.com, www.angiotech.com.\n\nHSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes.",
      "code_info": "Catalog # 660007000 Lot Number(s): 81781ODR; 82041OSH; 82741Q2H; 82871QBF; 83101QRH; 83431RC7; 90151RYF; 90471SME; 90681T3F; 91131TZL; 91461UMC; 92251W8Z; 92521WOC; 92861XCL; 92941XJ6; 93421YAU; 00531ZJM; 010320FR; 011020JE; 016121GL; 02102297; 0260231B.",
      "firm_fei_number": "1036710",
      "recalling_firm": "Medical Device Technologies, Inc.",
      "address_1": "3600 Sw 47th Ave",
      "city": "Gainesville",
      "state": "FL",
      "postal_code": "32608-7555",
      "additional_info_contact": "Jayme Wilson\n352-338-0440 Ext. 350",
      "reason_for_recall": "Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity.",
      "root_cause_description": "Packaging",
      "action": "The firm, Angiotech, sent an \"URGENT PRODUCT RECALL NOTIFICATION\" letter dated December 22, 2010 to its customers.  The letter describes the product, problem and actions to be taken.  The customers were instructed to review their current inventory, segregate the affected lot numbers and complete and return the attached Customer Acknowledgement Form via fax to our Quality Assurance department at 1.352.338.0662 or 1.800.333.0440 to arrange for return of the identified product.\n\nIf you have any questions concerning this notification, call (352) 338.0440 ext. 355 or ext 358.",
      "product_quantity": "921 boxes",
      "distribution_pattern": "Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.",
      "openfda": {
        "device_name": "Catheter Care Tray",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5130",
        "device_class": "2",
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