{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Minneapolis",
      "address_1": "2300 Berkshire Ln N",
      "reason_for_recall": "Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product.  Some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire.",
      "address_2": "",
      "product_quantity": "550 kits (OUS)",
      "code_info": "Manufacturing Lot : W18499722",
      "center_classification_date": "20130627",
      "distribution_pattern": "Worldwide Distribution - AUSTRIA, BELGIUM, SWITZERLAND, GERMANY, SPAIN, GREECE, HUNGARY, IRELAND, ISRAEL and  ITALY.",
      "state": "MN",
      "product_description": "Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014.    Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. lt is suitable for use in the hospital or home setting.",
      "report_date": "20130703",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Greatbatch Medical",
      "recall_number": "Z-1608-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "65464",
      "termination_date": "20140804",
      "more_code_info": "",
      "recall_initiation_date": "20130531",
      "postal_code": "55441-4575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}