{
  "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": "16 lots; 1852 units (multiple units per lot)",
      "code_info": "Product code 900-419, 16  lots:  112041449  112093941  112114601  113025847  113026169  113036364  113047313  113067871  113078327  113089073  113099292  131110077  131210815  140111228  140211670  140311939",
      "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": "LABOR & DELIVERY PAC -     1) NEEDLE HYPODERMIC 18G X 1% ST.  (2) DRAPE UNDERBUTTOCK WITH POUCH  (4) TOWELS ABSORBENT 15\" X 20\"  ( 1) FEEDING TUBE 8FR, 15\" LONG  ( 1) BEANNIES BABY  ( 1) SYRINGE 20cc WITHOUT NEEDLE LILOCK  ( 1) UMBILICAL CORD CLAMP ST.  ( 1) RECEIVING BLANKET 100% COTTON  ( 1) TOWELS CLOTH HUCK (BLUE)  (2) LEGGINGS W/7\" CUFF 30\" X 42\"  ( 1) BABY BLANKET 30 X 30 POLY ABS IMPERV.  ( 1) BOWL PLASTIC 80oz  ( 1) LID FOR BOWL 80oz CLEAR  (20) GAUZE SPONGE 4\" X 4\" 16PLY  (2) PAD OBSTETRICAL X-LARGE ST.  ( 1) PACKING VAGINAL XRD 4 X 36 8PLY  ( 1) TABLE COVER REINFORCED 50\" X 90\"  ( 1) DRAPE ABDOMINAL WITH TAPE 40\" X 54\"  (1 ) NEEDLE HYPODERMIC 21G X 1% ST.  (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK  (2) PVP SCRUB 8\" STICK SPONGES ST.  ( 1) EAR ULCER SYRINGE 2oz.  ( 1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED  (2) WRAPPER 30\" X 30\"  ( 1) PVP PAINT 8\" STICK SPONGE ST.  (2) GLOVE SURG DERMA PRENE #7 % PF  (1) TIME OUT BEACON NON WOVEN ST.  (1) VACUTAINER GREEN NAHEP 10ML    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-2324-2014",
      "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"
    }
  ]
}