{
  "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,
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    }
  },
  "results": [
    {
      "cfres_id": "131311",
      "product_res_number": "Z-0568-2015",
      "event_date_initiated": "2014-10-20",
      "event_date_posted": "2014-12-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-04-23",
      "res_event_number": "69666",
      "product_code": "FJS",
      "k_numbers": [
        "K093796",
        "K113354"
      ],
      "product_description": "ASEPT 2000 ml Drainage Bag, Ref No. 622280\n\nProduct Usage:\nThe ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.",
      "code_info": "Lot No. 1210-028",
      "firm_fei_number": "3013666218",
      "recalling_firm": "Pfm Medical Inc",
      "address_1": "1815 Aston Ave Ste 106 1815 Aston Ave",
      "address_2": "Ste 106",
      "city": "Carlsbad",
      "state": "CA",
      "postal_code": "92008-7340",
      "additional_info_contact": "760-758-8749",
      "reason_for_recall": "PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.",
      "root_cause_description": "Process control",
      "action": "PFm Medical sent an Urgent Device Recall Notification letter dated November 3, 2014 to all their customers who purchased the catheters and other medical devices.  The letter informs the customers of the problems identified and the actions to be taken.  Customers are instructed to complete the recall acknowledgement/reply form and fax it to (760) 758-1167 or email it to customerservice@pfmmedicalusa.com.  Customers with any questions are instructed to contact Jessica Greene at (760) 758-8749.",
      "product_quantity": "370 units",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of  MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.",
      "openfda": {
        "k_number": [
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        "registration_number": [
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          "3002807599",
          "3002807095",
          "2527072",
          "3013666218",
          "3007544634"
        ],
        "device_name": "Catheter, Peritoneal, Long-Term Indwelling",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
  ]
}