{
  "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": {
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  "results": [
    {
      "cfres_id": "113521",
      "product_res_number": "Z-0293-2013",
      "event_date_initiated": "2012-08-21",
      "event_date_posted": "2012-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-09-11",
      "res_event_number": "63322",
      "product_code": "LMF",
      "pma_numbers": [
        "P990004"
      ],
      "product_description": "ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ   08876, USA\n\nSURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and applying the matrix during surgery. SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.",
      "code_info": "PMA number P990004    Medical Device Listing Number  D100622  Product Code:  2991  Lot #  239091    Exp Mar-13 Lot #  238783    Exp Sep-13 Lot #  238635    Exp Mar-13 Lot #  237498    Exp Mar-13 Lot #  237119    Exp Mar-13 Lot #  235488    Exp Jan-13",
      "firm_fei_number": "2210968",
      "recalling_firm": "Ethicon, Inc.",
      "address_1": "US Highway 22 West",
      "city": "Somerville",
      "state": "NJ",
      "postal_code": "08876",
      "additional_info_contact": "877-384-4266",
      "reason_for_recall": "SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.",
      "root_cause_description": "Packaging",
      "action": "Ethicon Inc. sent an Urgent Product Information letter dated August 21, 2012, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.   Customers were instructed to inspect their inventory to determine if they have any of the affected product.  Affected product should be returned for replacement to Stericycle using the enclosed pre-paid shipping label.    Customers with questions should call 1-877-384-4266 or contact their Ethicon Biosurgery Sales Representative.\nFor questions regarding this recall call 877-384-4266.",
      "product_quantity": "45,200",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and the countries of Russia, China, and the European Union.",
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          "P830079",
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          "N17600",
          "P990030",
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        ],
        "device_name": "Agent, Absorbable Hemostatic, Collagen Based",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4490",
        "device_class": "3"
      }
    }
  ]
}