{
  "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 different 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": "6 lots; 127 units (multiple units per lot)",
      "code_info": "Product code 900-1393, 6 lots:  112041420  113078354  113109651  140211586  140312499  140613718",
      "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    ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF  (5) DRAPE % ECONOMY 53\" X 77\" LIF  ( 1) MAYO STAND COVER REINFORCED LIF  (7) DRAPE UTILITY WITH TAPE L/F  (8) HUCK CLOTH TOWELS WHITE L/F  (20) HUCK CLOTH TOWELS BLUE LIF  (1) MAYO TRAY LARGE LIF  (1) TABLE COVER BTC 77\" X 110\" HD FULL COVERAGE LIF  (6) 3/4 SHEET DRAPE REINFORCED LIF  (2) STOCKINETTE 9\" X 48\" LIF  (1) SPLIT SHEET BILATERAL 84\" X 80\" LIF  (3) DRAPE SHEET 41\" X 58\" SMS LIF  (4) Pr. GLOVES SURGEON #7 BIOGEL    OPEN HEART TRAY - HOSPITAL DAMAS - PACK B-    (1) PLASTIC RULER 12\" LONG   (2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F  (1) Pk. PEANUT SPONGE DISSECTOR ST.  (2) UTILITY BOWL 32 oz. LIF  (1) SKIN MARKER WITH RULER LIF   (2) UTILITY BOWL 16 oz. UF  (3) BULB SYRINGE 60cc UF   (1) MAYO TRAY SMALL L/F  (2) YANKAUER SUCT. TUBE WITHOUT VENT UF   (1) TRAY ORGANIZER FULL DEEP LIF  (5) SAPHENOUS VEIN CANNULA LIF   (40) LAP SPONGES PRE-WASH XRD UF  (2) ELASTIC BANDAGE 6\" X 5 yds. UF   (2) SUTURE BAG FLORAL  (2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF   (1) BLADE SHARP ALL ARROUND 69  (1) SURGICAL BLADE# 11 CARBON STEEL   (4) LITE GLOVES UF  (2) SURGICAL BLADE# 15 CARBON STEEL   (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL  (1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF   (2) POUCH INSTRUMENT  (2) SURGICAL BLADE# 10 CARBON STEEL   (30) GAUZE SPONGES 4\" X 4\" 16 PLY XRD UF  (2) CAUTERY PENCIL ROCKER SWITCH LIF   (2) POLISHER CAUTERY TIP UF  (1) LABEL SET, HEPARINE,SALINE   (2) ELASTIC BANDAGE 4\" X 5 yds. LIF  (1) TABLE COVER BTC 77\" X 110\" HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF  (2) COTION GLOVE HEAVY DUTY   (1) AORTIC MONITORING PRESS SET 5.0  (1) CONNECTOR Y 3/8\" X 3/8\" X 3/8\" LIF   (2) NEEDLE HYPODERMIC 22G X 1 % LIF  (1) BLADE 6.1 X 32.3 X 1.0MM   (1) SQUARE TWO PIECE 500cc GRADUATE  (2) CONNECTOR REDUCER   (1) NEEDLE BLADE/KNIFE 3.0MM    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-2389-2014",
      "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"
    }
  ]
}