{
  "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": [
    {
      "country": "United States",
      "city": "Fajardo",
      "address_1": "Calle Igualdad Final #7",
      "reason_for_recall": "Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.",
      "address_2": "",
      "product_quantity": "12 lots/88 units, multiple units per lot",
      "code_info": "Product code 900-2114, 12 lots  112030719  112041222  112051939  112083124  112093924  112125069  113025796  113026055  113026076  113036761  113057459  113088787",
      "center_classification_date": "20140829",
      "distribution_pattern": "Worldwide Distribution - US (nationwide) in the state of  Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.",
      "state": "PR",
      "product_description": "OPEN HEART  TRAY  PACK A  CONTENTS:\t  (1)  TABLE COVER BTC 77\" X 110\" HD FULL COVERAGE LIF (1)  MAYO STAND COVER REINFORCED L/F  (3)  TOWEL ABSORBENT 15\" X 20\" LIF  (1)  TABLE COVER REINFORCED 50\" X 90\" LIF (1)  SPLIT SHEET BILATERAL 84\" X 80\"  (12) % SHEET 60\" X 77\" DRAPE REINFORCED LIF (1)  MAYO TRAY LARGE  (1)  CV DRAPE SPLIT CARDIO WITH CLEAR ANEST. SC STD SMS (15) TOWELS CLOTH HUCK BLUE  (4)   TOWELS CLOTH HUCK WHITE  (2)   STOCKINETTE IMPERVIOUS 14\" X 48\" LIF (30) LAP SPONGE PREWASH 18\" X 18\" XRD LIF (1)  WRAPPER 54\" X 54\"  (3)  LITES GLOVE LIF    OPEN HEART TRAY  HOSPITAL HERMANOS MELENDEZ  PACKB    CONTENTS:\t(1) TABLE COVER BTC 77\" X 110\" HD FULL COVERAGE LIF  (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (2)  CATHETER THORACIC 32FR. STRAIGH  (2) PENCIL CAUTERY ROCKER SWITCH LIF  (3) TUBE SUCTION CONNECT W X 12' LIF  (2)  SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) LABEL SET, HEPARINE SALINE  (2)  CAUTERY TIP POLISHER LIF  (1) TABLE COVER REINFORCED 50\" X 90\" LIF (1) BANDAGE ELASTIC 6\" X 5yds LIF  (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF  (2)  SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1)  NEEDLE HYPODERMIC 25G X 5/8 ST.  (10) GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF  (1)  NEEDLE HYPODERMIC 27G X %\" ST.  (1)  NEEDLE & BLADE COUNTER 60C MAG/MAG (2) BOWL UTILITY 16oz.  (4)  FEEDING TUBE 8FR, 15\" LONG (2)  BULB SYRINGE 60cc  (1)  TRAY PLATFORM LARGE  (1)  SKIN MARKER WITH RULER  (1)  CATHETER 18FR SUCTION W/STRA LIF (1)  WRAPPER 54\" X 54\" UF  (1)  BLADE SURGICAL #10 CARBON STEEL (1)  BLADE SURGICAL #15 CARBON STEEL (2)  BLADE SURGICAL #11 CARBON STEEL (1)  BLADE SURGICAL #20 CARBON STEEL    OPEN HEART TRAY  HOSPITAL HERMANOS MELENDEZ  PACKC  CONTENTS:\t(9) TOWELS ABSORBENT 15\" X 20\" UF  (6) GOWN FAB REINFORCED SONTARA X-LARGE  (1) GOWN IMPERVIOUS XTRA REINFORCED X-LARGE TOWEL & WRAP LEVEL Ill  (1) TABLE COVER REINFORCED 44\" X 78\" UF      Product Usage:  EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.",
      "report_date": "20140910",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Customed, Inc",
      "recall_number": "Z-2433-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68536",
      "termination_date": "20170814",
      "more_code_info": "",
      "recall_initiation_date": "20140520",
      "postal_code": "00738",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}