{
  "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": "174658",
      "product_res_number": "Z-0274-2020",
      "event_date_initiated": "2019-06-11",
      "event_date_created": "2019-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-06-04",
      "res_event_number": "83301",
      "product_code": "NDS",
      "k_numbers": [
        "K103302"
      ],
      "product_description": "StemPro MSC SFM CTS\"",
      "code_info": "SKU#: A1033301;  Lot # 556094 (Exp 2/28/2010), 577934 (Exp 4/30/2010) , 883643 (Exp 12/30/2011), 987595 (Exp 6/30/2013), 1607880 (Exp 6/30/2016), 1936294 (Exp 11/30/2019), 1960237 (Exp 4/30/2020), 2015107 (Exp 10/30/2020), 2049317 (Exp 11/30/2020), 2074105 ( Exp2/28/2021)",
      "firm_fei_number": "1317268",
      "recalling_firm": "Life Technologies Corporation",
      "address_1": "3175 Staley Rd",
      "city": "Grand Island",
      "state": "NY",
      "postal_code": "14072-2028",
      "additional_info_contact": "Leah Arruda\n760-268-7494",
      "reason_for_recall": "Component was not tested by the supplier for adventitious agents",
      "root_cause_description": "Vendor change control",
      "action": "1. Examine your inventory immediately to determine if you have any of the referenced material on hand.\n2. If so, discontinue use immediately and discard per your local laws and regulations. \n3. Notify all affected users in your facility.\n4. If you have shipped this lot outside of your facility, notify those customers or facilities of this recall.\n\nTo EMEA cutomers: please complete the customer response sheet if you have confirmed visual evidence of media between the media bag and dust cover in your material.\nEmail a copy of the response sheet along with the recall letter to your local order support team.\n\n\nIf you have nay question, please call Technical support at 00 800 5345 5345 option 3 or email at eurotech@thermofisher.com",
      "product_quantity": "4724 Kits",
      "distribution_pattern": "StemPro¿ MSC SFM CTSTM distributed to the following states in the USA: AL, CA, CO, CT, DC, FL, GA, IA, IL, KS, MA, MD, MN, NC, NE, NJ, NY,OH, OR, PA, RI, TX, UT, VA, WA, WI.\n\nStemPro¿ MSC SFM CTSTM distributed Internationally to the following countries: Australia, Belgium, Brazil,  Canada, Chile, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Malaysia,  Netherlands, Pakistan, Poland, Republic of Korea, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, Vietnam.\n\nCTSTM Essential 8 Medium  distributed to the following states in the USA: CA, DC, FL, IA, IL, MA, MD, MN, NC, NY, WA, WI.\n\nCTSTM Essential 8 Medium distributed Internationally to the following countries:  Australia, Canada, China, France, Germany, India, Japan, Netherlands, Portugal, Republic of Korea, Saudi Arabia,  Singapore, Sweden, Switzerland, Taiwan, United Kingdom.",
      "openfda": {
        "k_number": [
          "K113566",
          "DEN000008",
          "K022086",
          "K201789",
          "K103302",
          "K100616",
          "K231804",
          "K232543",
          "K240247"
        ],
        "device_name": "Media, Culture, Ex Vivo, Tissue And Cell",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5885",
        "device_class": "2",
        "registration_number": [
          "3016633010"
        ],
        "fei_number": [
          "3016633010"
        ]
      }
    }
  ]
}