{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Braintree",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84183",
      "recalling_firm": "Haemonetics Corporation",
      "address_1": "400 Wood Rd",
      "address_2": "N/A",
      "postal_code": "02184-2412",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and countries of NZ, AU, IN, PK, PH, HK, VN, MY, ID, SG, CN, AT, DE, FR, GB,  IT, CH.",
      "recall_number": "Z-0895-2020",
      "product_description": "CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.",
      "product_quantity": "42739",
      "reason_for_recall": "Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.",
      "recall_initiation_date": "20191021",
      "center_classification_date": "20200129",
      "termination_date": "20201106",
      "report_date": "20200205",
      "code_info": "Catalog number/FG Item Number: CSE-FP-225V    1. Specific Lots with Bowl Cracks (7636 Distributed)  Lot number: 1902009HTT  1903001HTT  1903004HTT 1804008HTT  1804010HTT  1805004HTT  1805005HTT  1812012HTT  1901004HTT  1901005HTT  1901006HTT 1808007HTT 1808009HTT  1808012HTT  1809001HTT  1809002HTT  1809006HTT  1809009HTT  1810001HTT  1810003HTT  1901005HTT  1902009HTT  1810006HTT    2. Missing instructions to check for cracks in IFU  All products/lost manufactured between  October 2014 and October 2019."
    }
  ]
}