{
  "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": "19 lots; 968 units (multiple units per lot)",
      "code_info": "Product code 900-851,  19 lots:  112093954  112114401  112125118  113015517  113046987  113047162  113057510  113067939  113078349  113088895  113099457  113109877  131110317  140111098  140211857  140312187  140412474  140513147  140513483",
      "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) BEANNIES BABY LIF  (1) TABLE COVER REINFORCED 50\" X 90\" LIF  (1) COVER MAYO STAND REINFORCED LIF  (3) SHEET DRAPE 41 \" X 58\" SMS LIF  (5) TOWEL ABSORBENT 15\" X 20\" LIF  (15) SPONGE LAP PREWASH 18\" X 18\" XRD LIF  (1) YANKAUER SUCTION TUBE W/0 VENT L/F  (2) COUNTER NEEDLE & BLADE 10c MAG/CLEAR LIF  (2) PAD OBSTETRICAL X-LARGE LIF  (1) SYRINGE EAR/ULCER 2oz. L/F  (1) BLANKET BABY PRINTED  (1) TUBE SUCTION CONNECT Y-1\" X 12' LIF  (1) SYRINGE 20cc W/0 NEEDLE LUER LOCK LIF  (1) BLANKET RECEIVING 100% COTTON  (1) BOWL W/LID PLASTIC 80oz.  (1) UMBILICAL CORD CLAMP  (1) TUBE FEEDING PVC 8FR 15\" LONG  (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF  (1) BAG SUTURE FLORAL  (2) GLOVE MEDIUM FREETOUCH VYNIL POWDER FREE  (1) SCALPEL W/HANDLE #1 0  (1) SCALPEL W/HANDLE #20  (2) BOWL UTILITY 16oz. LIF  (1) PVP PAINT 8\" STICK SPONGE LIF  (1) GOWN SURG REINFORCED X-LARGE TOWEL/ WRAP LIF  (1) PENCIL CAUTERY HAND SWITCHING LIF  (1) SCISSOR UMBILICAL 4.5\" STRAIGHT  (1) WRAPPER 24\" X 24\" LIF  (1) PVP SCRUB 8\" STICK SPONGE LIF  (1) DRAPE C-SECTION W/POUCH 102\" X 121\" X 78\" LIF  (1) TIME OUT BEACON NON WOVEN LIF    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-2354-2014",
      "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"
    }
  ]
}