{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Brooklyn Park",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69746",
      "recalling_firm": "Medtronic Perfusion Systems",
      "address_1": "7611 Northland Dr N",
      "address_2": "N/A",
      "postal_code": "55428-1088",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Visit",
      "distribution_pattern": "US Distribution to states of: CA and FL.    UPDATED:    OUS: Czech Republic and Switzerland.",
      "recall_number": "Z-0531-2015",
      "product_description": "The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter.  The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function.  The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging.",
      "product_quantity": "66,   UPDATE:  168 additional devices.",
      "reason_for_recall": "Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers.  Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7.    UPDATED:    Recall was updated to incorporate three additional lots affected.",
      "recall_initiation_date": "20141031",
      "center_classification_date": "20141208",
      "termination_date": "20150811",
      "report_date": "20141217",
      "code_info": "Lot number 12981001 with the following Serial Numbers:    8110138055  8110141155  8110141281  8110141459  8110138056  8110141162  8110141304  8110141469  8110138061  8110141167  8110141305  8110141471  8110138096  8110141168  8110141315  8110141497  8110139306  8110141182  8110141320  8110141518  8110139330  8110141184  8110141331  8110141527  8110139856  8110141188  8110141335  8110141533  8110140819  8110141193  8110141342  8110141587  8110140824  8110141215  8110141368  8110141604  8110140985  8110141219  8110141380  8110141605  8110141045  8110141222  8110141391  8110141613  8110141082  8110141230  8110141403  8110141616  8110141083  8110141238  8110141415  8110141621  8110141114  8110141240  8110141416  8110141705  8110141119  8110141244  8110141418  8110141731  8110141127  8110141247  8110141421  8110141739  8110141128  8110141253  8110141423  8110141750  8110141138  8110141258  8110141431  8110141782  8110141142  8110141260  8110141445  8110141788  8110141153  8110141279  8110141452  8110141798    UPDATED:    Lot # 13011880, 13 (serial # 8110141520), 13023057 (Serial # 8110141435 and 8110141539)."
    }
  ]
}