{
  "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": "Deerfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88351",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "address_2": "N/A",
      "postal_code": "60015-4625",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-2378-2021",
      "product_description": "Baxter PrismaFlex, REF numbers:    a) 106696 (M 60 SET)  b) 106697 (M 100 SET)    Expansion:  c) 107144 (TPE2000 SET)  d) 115307 (M 150 SET)  e) 115309 (ST 100 SET)  f) 955467 (M 150 SET)  g) 955468 (ST 100 SET)  h) 955595 (M 100 SET)  i) 955596 (ST 150 SET)    Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.",
      "product_quantity": "64275 units",
      "reason_for_recall": "Products labeled as sterile were distributed, but may not have been sterilized.  \"\tBaxter confirmed Steril Milano observed nonconformances that were not reported to Baxter.  Data was manipulated to appear to be conforming",
      "recall_initiation_date": "20210722",
      "center_classification_date": "20210827",
      "termination_date": "20240117",
      "report_date": "20210908",
      "code_info": "a) 106696, Lot Numbers:  20B2329M  b) 106697, Lot Numbers:  20B2323M, 20B2328M (expanded to include 20B2326M) Expansion: c) 107144, Lot Number 20B2325M d) 115307, Lot  Number 20B2321M e) 115309, Lot Number 20B2310M and 20F0201 f) 955467, Lot Numbers 20A2604M, 20A2606M, 20A2607M, 20A2608M, 20B2331M, 20B2332M, 20B2333M, 20B2334M, 20B2335M, 20B2336M, 20B2347M, 20A2605M g) 955468, Lot Numbers 20A2602M, 20A2603M, 20B2308M, 20B2311M, 20B2312M, and 20B2324M h) 955595, Lot Numbers 20A2609M, 20A2610M, 20B2337M, 20B2338M, 20B2339M, 20B2340M, 20B2341M, 20B2342M, 20B2343M, 20B2344M, 20B2345M, and 20B2346M i) 955596, Lot Numbers 20A2601M, 20B2302M, and 20B2309M"
    }
  ]
}