{
  "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": "97542",
      "product_res_number": "Z-0244-2012",
      "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": "OJV",
      "product_description": "Angiotech*** Custom Bone Marrow Tray for Louis Weiss Memorial Hospital***1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2\" Needle; 1 - 21ga x 1-1/2\" Needle;  1 - 19ga x 1-1/2\" Filter Needle; 1 - 25ga x 5/8\" Needle; 1 - 1cc Syringe L/L; 1 - 5cc Syringe L/L; 2 - 10cc Syringe L/L; 1  Needle Safety Foam Block, Large; 1 - Fenestrated Drape; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4\" x 4\" Sponges in stacks of 5; 1 - 2\"x 3\" ADH Dressing; 1 - Towel; 4  Alcohol Swab Sticks;  20 - Micro Slides - Frosted end; 1 - T-Lok Extraction Cannula; 1 - 2% Lidocaine (10mL);  1 - 11ga x 4 Bone Marrow Needle J Type; 1 - Probe Guide; 1  Obturator.***Catalog Number:  CB0318TL***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\nIntended for the purpose of harvesting bone and/or bone marrow specimens.",
      "code_info": "Catalog # CB0318TL Lot Number(s):  91691V3N; 93201XW3; 0091208U.",
      "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": "24 boxes",
      "distribution_pattern": "Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.",
      "openfda": {
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        ],
        "device_name": "Single Use Instrument Tray",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4800",
        "device_class": "1"
      }
    }
  ]
}