{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "64546",
      "product_res_number": "Z-0057-2008",
      "event_date_initiated": "2007-03-27",
      "event_date_posted": "2007-10-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-10-07",
      "res_event_number": "44933",
      "product_code": "MED",
      "k_numbers": [
        "K932740"
      ],
      "product_description": "ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA  92630 U.S.A.",
      "code_info": "6A4171 (exp. MAR 2009), 694133 (exp. FEB 2009), 654920 (exp. OCT 2008), 5A4732 (exp. MAR 2008), 584699 (exp. JAN 2008)",
      "firm_fei_number": "3011270181",
      "recalling_firm": "I-Flow Corporation",
      "address_1": "20202 Windrow Dr",
      "city": "Lake Forest",
      "state": "CA",
      "postal_code": "92630-8152",
      "additional_info_contact": "Shane Noehre\n949-206-2653",
      "reason_for_recall": "Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker catheter. As a result, the bolus button may remain latched in the down position which may cause the the device to deliver continuously at 7 ml/hr instead of 2 ml/hr.",
      "root_cause_description": "Process control",
      "action": "An Important Recall Notification Letter was faxed to affected customers on March 27, 2007.  Affected customers were notified of the recall, the reason for recall, and instructed to immediately quarantine any remaining inventory.  A Customer Response (and Fax back) form was included with the Recall Notification.  Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt.  Replacement product will be sent out as applicable.",
      "product_quantity": "2,587 units",
      "distribution_pattern": "Worldwide, USA and Australia",
      "openfda": {
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        "registration_number": [
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        "fei_number": [
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        ],
        "device_name": "Sterilant, Medical Devices",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.6885",
        "device_class": "2"
      }
    }
  ]
}