{
  "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": "45458",
      "product_res_number": "Z-0802-06",
      "event_date_initiated": "2006-03-29",
      "event_date_posted": "2006-04-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-01-23",
      "res_event_number": "35148",
      "product_code": "MMP",
      "k_numbers": [
        "K942024"
      ],
      "product_description": "Locator-Wand  Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and  identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray.  REF 21-4672-24.  Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover,  Luer Cap, 20G PORT-A-CATH needle, 18G Blunt Needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information.   EtO Sterilized.  Single Use.   Deltec, Inc., St. Paul, MN  55112 U.S.A.",
      "code_info": "Re-order Number 21-4672-24, Lot numbers:  M41277, M42230, M42694, M42900",
      "firm_fei_number": "2183502",
      "recalling_firm": "Smiths Medical MD, Inc.",
      "address_1": "1265 Grey Fox Rd",
      "city": "Saint Paul",
      "state": "MN",
      "postal_code": "55112-6929",
      "reason_for_recall": "One lot of Locator-Wand Cover sterile pouches may have an insufficient seal and product sterility could be compromised.  The Locator-Wand Cover is supplied with the PORT-A-CATH II AND P.A.S. PORT systems.  The packaged Wand-Cover is placed on the outside of the PORT-A-CATH II AND P.A.S. PORT tray.",
      "root_cause_description": "Other",
      "action": "An Urgent Product Safety & Recall Notification, dated 03/29/06, was mailed to domestic customers and emailed to international customers.    The letter described the issue, identified re-order number and lot numbers affected and gave 3 options.  The options include to use only the sterile tray and discard the wand cover from the shelf box; remove and discard Locator-Wand Cover pouches and request replacement Locator-Wand Covers; or return the entire device for a credit or replacement.",
      "product_quantity": "181 trays",
      "distribution_pattern": "Nationwide.  AR, CA, DE, FL, IL, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OK, PA, TN, TX,  VA, WI.    Germany, Italy, Netherlands, Singapore, Spain",
      "openfda": {
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          "K931417",
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          "K032065",
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          "K040794",
          "K930552",
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          "K962288",
          "K091178",
          "K970885",
          "K820692",
          "K041501",
          "K043234",
          "K961699"
        ],
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        "fei_number": [
          "2936485",
          "1000117748",
          "1000138054",
          "3002902735",
          "3013046958",
          "3016761372",
          "3012494290",
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          "3002750084",
          "3001236905",
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          "3011494917",
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          "3015173212",
          "3033043422",
          "3004829691",
          "3004122598",
          "1625425",
          "3008850249"
        ],
        "device_name": "Cover, Barrier, Protective",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4370",
        "device_class": "2"
      }
    }
  ]
}