{
  "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": "Republic",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84643",
      "recalling_firm": "ROi CPS LLC",
      "address_1": "3000 E Sawyer Rd",
      "address_2": "N/A",
      "postal_code": "65738-2758",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US: AR, OK, MO, KS",
      "recall_number": "Z-0918-2020",
      "product_description": "Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows:  a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012  b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027  c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026  d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024  e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011  f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028  g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084  h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014  i)  regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA -  , Item Number 830034    Product Usage:    These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.",
      "product_quantity": "412 packs",
      "reason_for_recall": "ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.",
      "recall_initiation_date": "20200103",
      "center_classification_date": "20200130",
      "termination_date": "20201120",
      "report_date": "20200205",
      "code_info": "a) Item Number 830015012  Lot Numbers:  72700L, 74508L    b) Item Number: 830027  Lot Numbers:  72702C, 74406C    c) Item Number: 830026  Lot Numbers:  72897B    d) Item Number: 830024  Lot Numbers:  73325B, 74403B    e) Item Number, 880189011  Lot Numbers:  73173K, 74855K    f) Item Number: 830028  Lot Numbers:  73666B    g) Item Number 830084  Lot Numbers:  74354B    h) Item Number 830014  Lot Numbers:  74373N    i) Item Number 830034  Lot Numbers:  68336D"
    }
  ]
}