{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Powell",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85594",
      "recalling_firm": "DeRoyal Industries Inc",
      "address_1": "200 Debusk Ln",
      "address_2": "N/A",
      "postal_code": "37849-4703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US distribution in the states of TN, MD, MN, ND, NY, FL, MA, RI",
      "recall_number": "Z-1963-2020",
      "product_description": "DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows:  a. H* Vein Pack Pgybk, 89-6209.03      b. H* Vein Pack, 89-6209.04     c. PICC Line Tray Pgybk, 89-6150.12     d. Umbilical Arterial Cath, 89-9370.01      e. Port Pack Pgybk, 89-8748.03      f. Port Pack Pgybk, 89-8748.04     g. Central Line Pack Pgybk, 89-8448.02     h.CV Insertion Kit II Pgybk, 89-9417.03     I. CV Insertion Kit II Pgybk, 89-9417.04     j. Right Heart Introducer Pgybk, 89-8495.04     k. Vein Pack Pgybk, 89-10400.01",
      "product_quantity": "352 trays with 7923 syringes",
      "reason_for_recall": "DeRoyal manufactured procedure packs using BDPosiFlush  syringes which were subsequently recalled due holes in the packaging.",
      "recall_initiation_date": "20200424",
      "center_classification_date": "20200511",
      "termination_date": "20220526",
      "report_date": "20200520",
      "code_info": "a. 89-6209.03:  Lot number: 49935860 exp 4/1/2021    b. 89-6209.04:  Lot numbers: 51458994 exp 2/1/2022, 51220521 exp 2/1/2022, 51382467 exp 2/1/2022, 51836975 exp 4/1/2022, 51006728 exp 10/1/2021     c. 89-6150.12:  Lot numbers: 49896872 exp 11/1/2021, 50381438 exp 12/1/2021, 50129726 exp 12/1/2021, 51602562 exp 2/1/2022, 51347371 exp 2/1/2022, 51788951 exp 4/1/2022, 50784528 exp 8/1/2021, 51006787 exp 1/1/2022     d. 89-9370.01:  Lot numbers: 50110742 exp 7/1/2020, 50601672 exp 7/1/2020, 51008408 exp 5/1/2021, 51284787 exp 8/1/2021     e. 89-8748.03:  Lot Number 49989657 exp 12/1/2021      f. 89-8748.04:  Lot numbers: 50275125 exp 12/1/2021, 50129064 exp 12/1/2021, 51791631 exp 12/1/2021, 51434765 exp 2/1/2022, 51925556 exp 4/1/2022, 50879543 exp 1/1/2022, 51030197 exp 1/1/2022     g. 89-8448.02:  Lot numbers: 50477253 exp 10/1/2020, 50129072 exp 1/1/2021, 50570141 exp 2/1/2021     h.89-9417.03:  Lot number: 50375468 exp 10/1/2020    i. 89-9417.04:  Lot numbers: 51604074 exp 5/1/2021, 51733028 exp 5/1/2021, 52033357 exp 5/1/2021, 50630967 exp 2/1/2021, 50829255 exp 4/1/2021     j. 89-8495.04:  Lot numbers: 50612902 exp 10/1/2020, 51791800 exp 2/1/2021, 50905238 exp 2/1/2021, 50919891 exp 2/1/2021, 51252849 exp 2/1/2021     k. 89-10400.01:  Lot numbers: 51556261 exp 2/1/2021, 51881274 exp 2/1/2022, 51974930 exp 2/1/2022, 51473449 exp 10/1/2021, 51984388 exp 4/1/2022"
    }
  ]
}