{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "166431",
      "product_res_number": "Z-2957-2018",
      "event_date_initiated": "2018-05-30",
      "event_date_created": "2018-08-30",
      "recall_status": "Open, Classified",
      "res_event_number": "80757",
      "product_code": "PMX",
      "pma_numbers": [
        "P990009"
      ],
      "product_description": "FLOSEAL Special Applicator Tips in cartons labeled in part, \"Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***.\"  The pouches inside the cartons are labeled in part, \"Floseal SPECIAL APPLICATOR TIPS***Baxter***\".\"",
      "code_info": "Product Code: 1502186; Box Lot Numbers: HA170718, HA170818, and HA170917; Pouch Lot Numbers: GR338160 and GR338384",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "800-422-9837",
      "reason_for_recall": "Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips.",
      "root_cause_description": "Mixed-up of materials/components",
      "action": "Baxter Healthcare notified customers of the recall on 05/30/2018 via Urgent Product Recall letter to the Directors of Pharmacy.  Instructions included to locate and remove all affected product from inventory, contact Baxter Healthcare Center for Service to arrange for return of affected devices, complete and return the enclosed Baxter customer reply form, and notify customers if further distributed.  \n\nAdverse reactions to the product can be reported to FDA MedWatch Adverse Event Reporting program and/or Baxter Corporate Product Surveillance at 800-437-5176 between the hours of 8;00 AM and 5:00 PM Central Time, Monday through Friday.",
      "product_quantity": "46,908 pouches",
      "distribution_pattern": "Nationwide distribution to AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.    \n\nInternational distribution to Australia, Korea, Taiwan, Columbia.",
      "openfda": {
        "pma_number": [
          "P990030",
          "P990009",
          "P170012",
          "P050044"
        ],
        "registration_number": [
          "2937398",
          "3007702492",
          "3035387162",
          "2528981",
          "2953359",
          "1416980",
          "2029275",
          "1125612",
          "3010178296",
          "2011171",
          "3002907620",
          "3010162973"
        ],
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          "2937398",
          "3007702492",
          "1000306431",
          "3035387162",
          "2528981",
          "3003110073",
          "3002931663",
          "3002807041",
          "1416980",
          "2011171",
          "3002907620",
          "3000215205"
        ],
        "device_name": "Absorbable Collagen Hemostatic Agent With Thrombin",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4490",
        "device_class": "3"
      }
    }
  ]
}