{
  "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": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63769",
      "recalling_firm": "Medtronic Inc. Cardiac Rhythm Disease Management",
      "address_1": "8200 Coral Sea St NE",
      "address_2": "N/A",
      "postal_code": "55112-4391",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution--USA (nationwide) including the states of  AZ, CA, CT, FL, GA, IL IA, MD, MA, MI, MS, NJ, NY, OH, OK, SC, TN, TX and WI. and the countries of  CANADA and MALAYSIA.",
      "recall_number": "Z-0618-2013",
      "product_description": "Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers:    0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1.     Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432    Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer.",
      "product_quantity": "1552",
      "reason_for_recall": "Medtronic is initiating an Urgent Medical Device Customer Notification.  We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.",
      "recall_initiation_date": "20121119",
      "center_classification_date": "20121228",
      "termination_date": "20130404",
      "report_date": "20130109",
      "code_info": "Pack Model  Pack Lot  0E27R16- 11239917   11252800   11264666;  1A30R6- 12132577   12219267;  2493R24- 11187015   11199707   11224309   11227205   11556735;  2493R25- 11646941   11713200   11745242   11813334   11852673   11886412   11990393   12033630   12114699   12178107   12191642   12450856;  5D56R5- 11298229   11357085   11465358   11541270   11601193   11654853   11702415   11745232   11766305   11822320   11838721   11852677   11930380   12024708   12166379   12292156;  5Z93R4- 11713132   11736880   11749958   11766283   11808651   11860604   11878689   11911068   11948473  5Z93R5- 12236493;   12411746  7E64R2- 11933798;  7J53R2- 12172725;  7M13R1- 12168157;  7M14R1- 12349772;  7N16R- 12349786;  7P25R1- 12327801   12449801   12457250;  7P93R1- 12349795   12374420;  7Q11R1- 12344028   12456303;  BB7L63R2- 12408737;  BB7N26R- 12312571;  CB5174R11- 11293051   11315344                       11334856   11489271   11745162   11886341   11977682   12019852   12062713   12098852   12139621   12146752   12258941   12277502   12326468   12421465   206110946;   CB5175R13- 11292866   11334859   11432873   11442937   12182778   12411655;   CB5Q03R6- 11713162   11766245   11787583   11923139   11934952;   CB5Q03R7- 12114626;  CB6C53R6- 12423767;  CB7C15R2- 12411647;  CB7C59R2- 11731501;                       11813316   11838743   11869767   11908794                        11982413   12019907                       12146796   12151706   12201727   12292133   12423702;  CB7C60R2- 11687047                        11724030   11843434                        11878672;  CB7C74R2- 11895167;  CB7D91R5- 11961280   12130493   12146882   12191604   12277455   12411687   12423760;   CB7E35R2- 11839101;   CB7E38R1- 11843886   11885844   11990360                       12105025   12133083   12159400;   CB7G21R4- 12032413   12033728   12040524   12083359   12360622;   CB7L48R1- 12301694;  CB7L72R1- 12155258;  CB7P82R1- 12440601;  HY6U96R2- 206133995;  HY6Y52R2- 11826276;  HY7E87R1- 11830948   11898103   11923498   12323794   12435409;  SS7J91R3- 12175428;  SSCB7L48R- 12120109;  SSTL7G78R1 -11986264;  TL5S33R7- 12093478;   12139612   12172589   12315375;   TL6V77R1- 11217931   11260111;   TL7B51R1- 11559097   11622968   11664762   11687063   11712834;   TL7G20R3- 12258680   12271138   12360554  TL7G78R3- 12067309;  TL7R87R1- 206114578   206145379"
    }
  ]
}