{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48696",
      "product_res_number": "Z-0066-2007",
      "event_date_initiated": "2006-09-27",
      "event_date_posted": "2006-10-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-12-30",
      "res_event_number": "36466",
      "product_code": "MMP",
      "k_numbers": [
        "K871132",
        "K931073",
        "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 II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray.  REF 21-4683-24.  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, 18G Blunt needle, 20G GRIPPER PLUS non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr introducer, 2 ''J'' Guidewires, 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": "Lot number M42880",
      "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": "Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006.  The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.",
      "root_cause_description": "Other",
      "action": "An Urgent Product Safety & Recall Notification, dated 09/27/06, was sent to customers via facsimile and phone calls were made. The letter describes the issue and customers are given 3 options to include: use only the sterile tray and discard the wand cover, 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": "1 tray",
      "distribution_pattern": "CA, FL, MA, MD, OH, OK, TX",
      "openfda": {
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          "K931417",
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          "K930552",
          "K970885",
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          "K961699",
          "K820692",
          "K952241",
          "K014239",
          "K041501",
          "K040794",
          "K032065",
          "K091178",
          "K962288"
        ],
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        "fei_number": [
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          "3006581049",
          "3009544661",
          "3007007790",
          "3002750084",
          "3011494917",
          "3012494290",
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          "3000210101",
          "3002914049",
          "3016761372",
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          "1018470",
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          "3004362278",
          "3007082897",
          "3004111573",
          "3002939620"
        ],
        "device_name": "Cover, Barrier, Protective",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4370",
        "device_class": "2"
      }
    }
  ]
}