{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "94904",
      "product_res_number": "Z-0170-2011",
      "event_date_initiated": "2010-09-27",
      "event_date_posted": "2010-11-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-04-17",
      "res_event_number": "56909",
      "product_code": "LPB",
      "pma_numbers": [
        "P980003",
        "P990054"
      ],
      "product_description": "Boston Scientific Peristaltic Tubing Kit, Model 2104,  UPN M0043521040.  For use with Boston Scientific CHILLI Cooled Ablation Catheters and Model 8005 Continuous Operation Pump.   Sterilized using Ethylene Oxide.  Contents:  peristaltic pump fluid delivery extension tube set.  Manufactured for:  Boston Scientific Corporation, One Boston Scientific Place, Natick, MA  01760-1537, USA.\nTubing Set (model 2104) for use with Boston Scientific Cooled Ablation System.",
      "code_info": "Lot:  61035169, 61071543, 61066975, 61066976, 61088879, 61088880, 61088881, 61088882, 61090636",
      "firm_fei_number": "3002095335",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "city": "Maple Grove",
      "state": "MN",
      "postal_code": "55311-1565",
      "additional_info_contact": "Bob Ware\n510-624-2563",
      "reason_for_recall": "Boston Scientific is conducting a Recall on CircuCool Tubing Sets used with the Chilli II Cooled Ablation System because there may be a potential for a sterile barrier breach which could compromise device sterility and potentially the sterile field.  Even though there have been no reported complaints.",
      "root_cause_description": "Packaging",
      "action": "Boston Scientific Corporation sent an Urgent Medical Device Recall letter, dated September 27, 2010, to all customers via overnight Federal Express.  The letter described the product, the problem, and the action the customer should take.  The letter instructed customers to cease distribution of affected devices and remove them from their inventory, segregate in a secure location for return to Boston Scientific.  A Reply Verification Tracking Form was to be completed and returned via email or faxed to (510) 624-2475 even if the customer did not have any of the affected product.  \nIf affected units were located the customer was to call (510) 624-2563 to obtain a Returned Good Authorization (RGA) Number and return to:\nBoston Scientific Corporation\nUS Distribution Center\nBoston Scientific Marina Bay\nCustomer Fulfillment Center\n500 Commander Shea Blvd.\nQuincy, Massachusetts 02171\nRGA: _________________\n\nFor additional questions call (510) 624-2563.",
      "product_quantity": "4031 US , 663 OUS",
      "distribution_pattern": "Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV and the countries of France, Germany, Great Britain, Hungary, Israel, Italy, Netherlands, Saudi Arabia, Spain, and Taiwan",
      "openfda": {
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          "P020045",
          "P110016",
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          "P030031",
          "P060019",
          "P930029",
          "P990054",
          "P000020",
          "P980003",
          "P050029",
          "P990025",
          "P920047",
          "P990071",
          "P040014"
        ],
        "registration_number": [
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          "3003058448",
          "3007029079",
          "3013300026",
          "3012552532",
          "3005700659"
        ],
        "device_name": "Cardiac Ablation Percutaneous Catheter",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}