{
  "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": "45457",
      "product_res_number": "Z-0801-06",
      "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": [
        "K871132",
        "K931073"
      ],
      "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 II Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. tray.  REF 21-4655-24.  Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow Polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented  Luer Cap, 20G PORT-A-CATH needle, 16G Blunt Needle, 20G GRIPPER PLUS Non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 8.5 Fr Introducer, ''J'' Guidewire, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information.   EtO Sterilized.  Single Use.   Deltec, Inc., St. Paul, MN  55112 U.S.A.",
      "code_info": "Re-order Number 21-4655-24, Lot numbers M42087, M43079",
      "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": "73 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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        "fei_number": [
          "2936485",
          "1000117748",
          "1000138054",
          "3002902735",
          "3013046958",
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          "1625425",
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        ],
        "device_name": "Cover, Barrier, Protective",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4370",
        "device_class": "2"
      }
    }
  ]
}