{
  "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": "141378",
      "product_res_number": "Z-0361-2016",
      "event_date_initiated": "2015-10-28",
      "event_date_posted": "2015-12-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-11-17",
      "res_event_number": "72524",
      "product_code": "DTR",
      "k_numbers": [
        "K953838"
      ],
      "product_description": "Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.",
      "code_info": "0491795E04, 0492175E04, 0492185E06, 0492195E06, 0492615E06, 0492625E08, 0492635E08, 0489905Y04, 0490245Y06, 0493075U02, 0493085U02, 0493435U04,  0493675U04, 0493685U07, 494465U07, 0494475U09, 0494855G01, 0495215U11, 0495225U11, 0495505G02, 495515G02, 0496535G08, 0496875G08, 496885G08, 0497245S02, 0495205U11, 497255S04, 0497655S04, 0498535S06, 0498545S06, 0492205E03, 0493695U04, 0494485U07, 0495525G02, 0497265S02, 0495965G04, 0492765E07",
      "firm_fei_number": "3001665800",
      "recalling_firm": "Quest Medical, Inc.",
      "address_1": "1 Allentown Pkwy",
      "city": "Allen",
      "state": "TX",
      "postal_code": "75002-4206",
      "additional_info_contact": "Amy Clendening-Wheeler\n972-390-9800",
      "reason_for_recall": "The products have been found to intermittently exhibit a seal failure during use.",
      "root_cause_description": "Equipment maintenance",
      "action": "The recalling firm issued a press release on 10/28/2015.  The press release was posted on FDA website on 10/29/2015.  The recalling firm emailed affected consignees on 10/28/15 and sent out recall letters via USPS beginning 10/30/15.",
      "product_quantity": "18,761 units",
      "distribution_pattern": "Distributed US (nationwide) and the countries of  Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.",
      "openfda": {
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        "registration_number": [
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        "device_name": "Heat-Exchanger, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4240",
        "device_class": "2"
      }
    }
  ]
}