{
  "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": "Eysins",
      "state": "N/A",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85525",
      "recalling_firm": "BD SWITZERLAND SARL",
      "address_1": "Terre Bonne Park A4",
      "address_2": "Route De Crassier 17",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.",
      "recall_number": "Z-1968-2020",
      "product_description": "BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique   Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes:   The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy.   Antisiphon sets cannot be primed by gravity.",
      "product_quantity": "110,350",
      "reason_for_recall": "The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.",
      "recall_initiation_date": "20200409",
      "center_classification_date": "20200513",
      "termination_date": "20201102",
      "report_date": "20200520",
      "code_info": "UDI: 10885403234422; Lot Numbers: 19016200  19045273"
    }
  ]
}