{
  "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": "14 lots; 420 units (multiple units per lot)",
      "code_info": "Product code 900-2005, 14 lots:  111123199  112030704  112041279  112051918  112083420  112125056  113036459  113047202  113057860  113078296  113088780  113109780  140211726  140412462",
      "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": "CESAREAN PACK -   (1) BABY BLANKET IMP. POLY ABS.   (4) ABSORBENT TOWELS 15\" x 20\" LIF  (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF   (2) LITE GLOVES LIF  (1) BOWL PLASTIC WITH LID 80 oz.   (1) C-SECTION DRAPE W/ POUCH 102\" X 121 \" X 78\"  (1) UTILITY BOWL 32 oz.   (10) LAP SPONGES PRE-WASHED XRD LIF  (2) PAD OBSTETRICAL XLGE   (1) BABY BEANNIES  (1) MAYO STAND COVER REINFORCED L/F   (1) DRAPE SHEET 41\" X 58\" SMS LIF  (1) TUBE SUCTION CONNECT. X\" X 12' L/F   (1) EAR ULCER SYRINGE 2oz. LIF  (1) RECEIVING BLANKET 100% COTION   (1) YANKAUER SUCT TUBE WITHOUT VENT L/F  (1) UMBILICAL CORD CLAMP   (2) WRAPPER 20\"X 20\"  (1) DRESSING ISLAND 4\" X 10\"   (1) SCALPEL# 10 WITH HANDLE S/S  (1) SCALPEL# 20 WITH HANDLE   (1) TABLE COVER REINFORCED 50\" X 90\" L/F  (1) MAYO TRAY SMALL   (1) MUCUSTRAP 20cc 1 OFr.  (2) GOWN LGE SMS IMPERVIOUS REINFORCED   (1) SURGICAL DURAPREP SOLUTION 26mL L/F    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-2430-2014",
      "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"
    }
  ]
}