{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Powell",
      "address_1": "200 Debusk Ln",
      "reason_for_recall": "These custom sterile surgical kits contain the component, ECOLAB ORS Fluid Warming and Slush Drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.",
      "address_2": "",
      "product_quantity": "836 units",
      "code_info": "Ref 89-7859.01: Lot numbers: 27369748, 27469087, 27964707, 28167081, 28207599, 28712544;   Ref 89-7859.02: Lot numbers: 35947501, 35550352, 38844461  Ref 89-7750.02: Lot numbers: 29929171, 30474952  Ref 89-7750.03: Lot numbers: 30984021, 31210924  Ref 89-8514.02: Lot numbers: 37392319, 37078506, 37109721, 36974376, 37057289, 36813530, 37086725, 37099609, 37253124, 37325378, 37401318, 37413132  Ref 89-5792.10: Lot numbers: 39821181, 39507167, 39072116, 39863866  Ref 89-7626.02: Lot numbers: 36068496, 359097163, 35543822, 35328356, 35428242, 35549693, 34939471, 33091009, 34952712  Ref 89-7626.03: Lot numbers: 39301960, 36660692, 37008882, 37210095, 37915491, 37217991, 40101164, 37519742, 38455852, 38756495, 39417057, 39714051, 39913835  Ref 89-8440.01: Lot numbers: 36674648, 36612412  Ref 89-8440.02: Lot number: 36987476",
      "center_classification_date": "20151202",
      "distribution_pattern": "Distributed in MO, MA, NC, CT, Kuwait.",
      "state": "TN",
      "product_description": "DeRoyal sterile custom surgical kits:  1) Emergency CABG Pack Pgybk, ref 89-7859.01  2) Emergency CABG Pack Pgybk, ref 89-7859.02  3) Open Heart Pack A&B Pgybk, ref 89-7750.02  4) Open Heart Pack A&B Pgybk, ref 89-7750.03  5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02    GEO-MED sterile custom surgical kits:  1) Open Heart Pack Pgybk, ref 89-5792.10  2) Open Heart A&B Pgybk, ref 89-7626.02  3) Open Heart A&B Pgybk, ref 89-7626.03  4) Open Heat Pack A&B Pgybk, ref 89-8440.01  5) Open Heart Pack A&B Pgybk, ref 89-8440.02",
      "report_date": "20151209",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "DeRoyal Industries Inc",
      "recall_number": "Z-0363-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "72574",
      "termination_date": "20180622",
      "more_code_info": "",
      "recall_initiation_date": "20150910",
      "postal_code": "37849-4703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}