{
  "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": "34 lots; 2648 units (multiple units per lot)",
      "code_info": "Product code 900-168,  34 lots:  110061523  110092042  110092166  110092388  110112612  110123053  111010060  111020331  111041058  111051332  111061506  111071775  111082059  111102842  111113023  111123371  112072440  112083401  112114642  112125025  113026049  113036454  113036752  113057838  113078270  113088750  113089158  113109744  131110336  140111166  140211649  140211925  140513102  140513461",
      "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": "Customed LABOR & DELIVERY PACK  - Includes:   (1) TABLE COVER 44\" x 90\"  (2) LEGGINS WITH/7\" CUFF 30\" x 42\"  (5) ABSORBENT TOWELS 15\" x 20\" LIF  (1) BABY BLANKET PRINTED LIF  (2) PAD OBSTETRICAL XLGE LIF  (1) EAR ULCER SYRINGE 2oz. LIF  (1) BABY BLANKET POLY ABS. IMP. LIF  (1) Pr. SURGICAL GLOVE # 7Y2  (1) UNDER BUTTOCK DRAPE WITH POUCH  (1) BEANNIES BABY LIF  (1) FEEDING TUBE 8 Fr. 15\" LONG LIF  (1) ABDOMINAL DRAPE WITH TAPE L/F  (1) DRAPE SHEET 41 \" X 58\" SMS  (1) GOWN SURG. REINFORCED X-LARGE SMS LEVEL IV  (1) VAGINAL SPONGE XRD  (1) UMBILICAL CORD CLAMP LIF  (2) CLOTH HUCK TOWELS BLUE  (1 0) GAUZE SPONGE 4\" X 4\"16 PLY XRD LIF  (1) SYRINGE 1 Occ WITH NEEDLE 21 X 1 Y2  (1) MUCUSTRAP 20cc 1 OFr.  (1) BOWL PLASTIC 80oz WITH LID  (1) WRAPPER 24\" X 24\" 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-2309-2014",
      "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"
    }
  ]
}