{
  "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": "Elkton",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "65981",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "125 Blue Ball Rd",
      "address_2": "N/A",
      "postal_code": "21921-5315",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution including WA, IN, OK, TX, MI, CA, NY, CT, AZ, FL, WV, NC, VA, PA, TN, GA, AL, MA, SC, OH, MS, MO, SD, WI, AR, AND NV.",
      "recall_number": "Z-2261-2013",
      "product_description": "Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit    Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.",
      "product_quantity": "15,817 filters",
      "reason_for_recall": "Medical device used in cardiovascular procedures is defective.",
      "recall_initiation_date": "20130726",
      "center_classification_date": "20130920",
      "termination_date": "20150728",
      "report_date": "20131002",
      "code_info": "Recalled filters sold singly are identified with Part Number AL6X with the following lot codes:    MM19,                            MN23,                            NC15,                            ND01,                            ND08,                            ND29,                           NE11,                            NE18,                            NE25,                            NF09,                            NF31,                            PA23,                            PD05,                            PE02,                            PF14,                            PF21,                            PG04,                            PG11,                            PG18,                            PG25,                            PH09,                            PH16,                            PH30,                            PK06,                            PK13,                            PL24,                            PM01,                            PM08,                            PM22,                            PM29,                            PN12,                            PN26,                            PP17,                            PP31,                            QA07,                            QA14,                            QA21,                            QC04,                            QC25,                            QD11,                            QD18,                            QD25,                            QE08,                            QE15,                            QE22,                            QE29,                            QF06,   QF28,  MM26,                            NL12,                            NM24,                            NP12, and PA30;                                                                                                                      Affected filters, also Part # AL6X, packaged within Terumo Cardiovascular Convenience Kits are identified with the following lot codes:    PN19,                            QA14,                            QC11R,                           QD04,                            QE15,                            QF06,                            QF13,                            NM31,                            NP05,                            PC20,                            PD05,                            QF28,                            QC04,                            PD26,                            PG04,                            PE23R,                           PK13,                            PK20,                            QA21,                            QC11,                            QC11A,                           QD11,                            QE01,                            PL17,                            QE08,                            NK08,                            PG25,                            PN26,                            QC18,                           NN07,                            NN07R,                           PA16,                            PA16R,                           PC27,                            PC27R,                           PF07,                            PL24,                            PD12,                            PE09,                            PE30,                            PH09,                            PL10,                            PE23,                            PF14,                            PG18,                            PK06,                            PM01,                            PM22,                            PN12,                            QA02,                           QA28,                            QC25,                            QD25,                            NK01,                            NK08R,                           PH23,                            PH16,                            PL10A,                           PM15,                            PP10,                            PP17,                            QD18,                            QE22,                            NM17,                            NM17A,                           PC06,                            PC06R,                           PE09R,                           QE01A,                           QE15A,                           QE15T,                           QE15TA,                          QE15TC,                          QF13T,                           QF20,                            QF20T,                           NA10R,                           NA17R,                           ND14,                            ND28,                            ND28T,                           NE11T,                           NE18,                            NF23,                            NG06,                            NG20,                            NH11,                            NH18,                           NK15,                            NL12,                            NL26,                            NM03,                            NM10,                            NM24,                            NN14,                            NN28,                            NP12,                            PA30,                            PC13,                            PD19,                            PE16,                            PF07A,                           PF21,                            PK27,                            PK27A,                           PL04,                            PM08,                            PP03,                            QA14T,                           QE29,                            QF28T,                           QF28TA,                          PG11,                            PH30,                            PH30A,                           PN26A,                           QA07,                            NH25,                            NK29,                            PE02,                            PF29,                            PN19,                            QG17,                            PK13A,                           QD11A,                           MN22,                            NE25,                            NF31,                            PM29,                            PA09,                            QG03,                            PA02,                            PH23T,                         PG11T,                           QC18R,                           QF06A,                           PH09T,                           PH09TA,                          QF13TA,                          QF20TA, and QF20TC"
    }
  ]
}