{
  "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": {
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  "results": [
    {
      "cfres_id": "184566",
      "product_res_number": "Z-0716-2021",
      "event_date_initiated": "2020-10-29",
      "event_date_created": "2020-12-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-01-11",
      "res_event_number": "86797",
      "product_code": "MJN",
      "k_numbers": [
        "K193440"
      ],
      "product_description": "PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.",
      "code_info": "Lot # 205936",
      "firm_fei_number": "3012279212",
      "recalling_firm": "Prytime Medical Devices, Inc.",
      "address_1": "229 N Main St",
      "city": "Boerne",
      "state": "TX",
      "postal_code": "78006-2035",
      "reason_for_recall": "There is a potential that  catheters may have incorrectly marked balloon  and arterial lines.  This could result in a  procedure  delay or injury to the patient.",
      "root_cause_description": "Labeling design",
      "action": "On October 29, 2020 the firm sent an \"Urgent Medical Device Recall Notification\" letter to consignees via FedEx.  In addition to informing the consignees about the recall, the firm ask customers to take the following actions:\n\n1. Please immediately quarantine and do NOT use  the affected lot. \n\n2. A Prytime representative  will visit your facility  and  retrieve the units from the affected lot from you at that time, and return them.\n\n3. If you have any questions or discover any additional ER-REBOA PLUS Catheters from Lot 205936 please contact me by phone at (210) 340-0116, or by email at byoung@prytimemedical.com.",
      "product_quantity": "3 units",
      "distribution_pattern": "US Nationwide distribution in the state of Utah.",
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        "device_name": "Catheter, Intravascular Occluding, Temporary",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4450",
        "device_class": "2"
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}