{
  "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": [
    {
      "status": "Terminated",
      "city": "Montreal",
      "state": "",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75474",
      "recalling_firm": "Baylis Medical Corp *",
      "address_1": "5959 TransCanada Highway",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution -- US, Canada, Chile, France, Germany, Hong Kong, Ireland, Italy, Mexico, Netherlands, Spain, UAE, and UK.",
      "recall_number": "Z-0393-2017",
      "product_description": "NRG Transseptal Needle and NRG RF Transseptal Kit.    Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0.     The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is individually packaged in a Tyvek/nylon pouch.    Used to create an atrial septal defect  in the heart.",
      "product_quantity": "28,093 units",
      "reason_for_recall": "The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG  Transseptal Needle.",
      "recall_initiation_date": "20161011",
      "center_classification_date": "20161110",
      "termination_date": "20170710",
      "report_date": "20161116",
      "code_info": "Lot numbers: NGFA240216  NGFC041115  NGFH211215  NGFA071015  NGFA151215  NGFB021115  NGFB090216  NGFB090616  NGFB101115  NGFB220216  NGFB231115  NGFB281015  NGFC110416  NGFC120116  NGFC180416  NGFC211015  NGFC250116  NGFC301115  NGFD030616  NGFD080716  NGFD091215  NGFD171115  NGFD250416  NGFE020216  NGFE090516  NGFE200116  NGFE240516  NGFF180716  NGFF211215  NGFH210316  NGFH290416  NGFI120216  NGFI270616  NGFA211015  NGFB111115  NGFB120116  NGFB140316  NGFB200616  NGFB271015  NGFC090516  NGFC161115  NGFC211215  NGFD021115  NGFD081215  NGFD160516  NGFE050116  NGFE090216  NGFE120216  NGFE290416  NGFF220216  NGFF231115  NGFF250416  NGFF270616  NGFF301115  NGFG240316  NGFG260116  NGFG300516  NGFH240516  NGFH290216  NGFI020216  NGFI210316  NGFD220216  NGFF050116  NGFA250116  NGFA240516  NGFD111115  NGFF180416  NGFH140316  NGFH151215  NGFI090616  NGFA241215  NGFB041115  NGFB070316  NGFC020216  NGFC060116  NGFC080816  NGFC120216  NGFC290416  NGFD110116  NGFD210316  NGFE200616  NGFG151215  NGFI250416  NGFB300415  NGFD040915  NGFG140715  NGFB301115  NGFA020316  NGFA030616  NGFA081215  NGFA120216  NGFA211215  NGFA270616  NGFB110116  NGFC071015  NGFC090616  NGFC240316  NGFC240516  NGFD090516  NGFD260116  NGFE040416  NGFE250416  NGFE300616  NGFF070316  NGFF110416  NGFF140316  NGFG180416  NGFJ290416  NGFA081015  NGFA210316  NGFA210616  NGFA240316  NGFA271015  NGFA301115  NGFA310316  NGFB020216  NGFB020316  NGFB030616  NGFB050516  NGFB080716  NGFB090516  NGFB120816  NGFB161115  NGFB270616  NGFB300616  NGFC151215  NGFC160516  NGFC300516  NGFD120216  NGFE020816  NGFE070316  NGFE190116  NGFF290216  NGFG040416  NGFG050116  NGFG140316  NGFG290416  NGFH110416  NGFH180716  NGFI180416  NGFI290416  NGFB180716  NGFB081215  NGFB171115  NGFB210316  NGFB240516  NGFC151015  NGFF190116  NGFF240316  NGFG090616  NGFI110416  NGFA021115  NGFA050516  NGFA090216  NGFA090516  NGFA160516  NGFA161115  NGFA300616  NGFC030616  NGFC110116  NGFD020816  NGFE180416  NGFF151215  NGFG151015  NGFH040416  NGFH090616  NGFJ240316  NGFJ290216  NGFA071215  NGFA190516  NGFB071015  NGFB200116  NGFB290216  NGFD271015  NGFF020216  NGFH180416  NGFH300516  NGFA101115  NGFB081015  NGFB091215  NGFB240316  NGFC200616  NGFD070316  NGFD090616  NGFD211015  NGFD231115  NGFD240516  NGFE030616  NGFE211215  NGFE270616  NGFF120116  NGFF210316  NGFF260116  NGFG120216  NGFH090216  NGFI220216  NGFJ180416  NGFM250416  NGFA300415  NGFB270815  NGFE140715  NGFJ050815  NGFH260116  NGFB120216  NGFC081015  NGFE111115  NGFE260116  NGFG200616  NGFK290216  NGFA190116  NGFB211015  NGFD090216  NGFE140316  NGFF200616  NGFG250416  NTFA160316  NTFA170316  NTFA290616  NTFH040216  NTFB170316  NTFD040216  NTFA020816  NTFA080616  NTFA210316  NTFB170816  NTFA170816  NTFA200716  NTFB100816  NTFB200716  NTFC040216  NTFC170316  NTFC170816",
      "more_code_info": ""
    }
  ]
}