{
  "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": "42 lots; 4790 units (multiple units per lot)",
      "code_info": "Product code 900-635,  42 lots:  110040968  110051274  110051406  110092404  110112815  110112897  111020476  111030646  111041113  111051299  111061558  111071830  111082247  111092399  111102773  111112950  111123278  112020492  112041343  112083439  112093730  112125105  112125304  113015514  113036673  113036736  113047027  113057609  113067934  113068178  113088881  113099448  113109866  113507497  131110310  131210835  140111242  140211675  140211944  140312385  140412840  140513250",
      "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": "PERY GYN PACK-    (1) DRAPE UTILITY WITH TAPE UF   (1) UNDERBUTTOCK DRAPE WITH POUCH  (2) ABSORBENT TOWELS 15\" x 20\" UF   (2) LEGGINS W/7'' CUFF 30\" X 42\"  (1) TABLE COVER REINFORCED 50\" X 90\" UF   (1) ABDOMINAL DRAPE WITH TAPE UF  (1) UTILITY BOWL 16oz.   (1 0) GAUZE SPONGE 4\" X 4\" 16PL Y XRD UF  (1) PAD OBSTETRICAL XL LIF   (2) SPECIMEN CONTAINER 4oz. W/LID & LABEL  (1 ) SYRINGE 1 Occ PREFILLED W/GEL   (1 ) DRAPE SHEET 41 \" X 69\" MEDIUM UF  (1 ) CATHETER 14FR. ROB. NELAT   (1) NON-ADHESIVE TELFA DRESSING  (2) GOWN IMP. REINFORCED LGE SMS    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-2341-2014",
      "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"
    }
  ]
}