{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lake Forest",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62769",
      "recalling_firm": "I-Flow Corporation",
      "address_1": "20202 Windrow Dr",
      "address_2": "N/A",
      "postal_code": "92630-8152",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution -- USA, Canada, Australia, the EU (Germany), United Arab Emirates, and Cyprus.",
      "recall_number": "Z-2253-2012",
      "product_description": "ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01.     Part Numbers: 101347100, 101347300, 101347400, 101360200, 101368400, 101368600, 101368700, 102987000, 102987200, 102987300, 103161800, 103534300, 5001438, 5001470, 5001651, 5001780, 5001808, 5001809, 5001812, 7000180, 7000181, 7000182, & 7000367.    Indicated for continuous and or intermittent delivery of medication to or around surgical wound sites and or close proximity to nerves.",
      "product_quantity": "80,646 units total (65,926 units in US)",
      "reason_for_recall": "It was determined that in a small quantity of ON-Q pumps with ONDEMAND, the bolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowermost position.  As a result, the patient may receive continuous infusion at a rate greater than expected.",
      "recall_initiation_date": "20120508",
      "center_classification_date": "20120827",
      "termination_date": "20130425",
      "report_date": "20120905",
      "code_info": "Products having a 10-digit Lot # that is greater than 0200521454  (i.e. 0200521455 and greater) are not impacted by this recall."
    }
  ]
}