{
  "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": "4 lots/112 units (multiple units per lot)",
      "code_info": "Product code 900-2438 ,4 lots  140211465  140211702  140412558  140512912",
      "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": "EXTREMITY ARM PACK  CONTENTS:\t  (1) \tSTOCKINETTE IMPERVIOUS  14\" X 48\"  (1) \tGOBAN SELF-ADHERENT WRAP 6\" X 5yds  (3) \tBANDAGE ELASTIC 4\" X 5yds  (1) \tBANDAGE ESMARK 6\" X 9  \t(1) \tUTILITY  BOWL QUART 32oz  (10)  GAUZE SPONGE 4\" X 4\" 16PLY  (1) \tTUBE SUCTION CONNECTX 12'  (1)    SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (3)    SCALPEL WITH HANDLE# 15 STAINLESS STEEL (1)    TIME OUT BEACON NON WOVEN  (1) \tLIGHT SHIELD  (1) \tDRAPE INCISE ANTIMICROBIAL 23\" X 17\"  (2) \tNEEDLE & BLADE COUNTER 10c MAG/CLEAR (1) \tU-DRAPE 60\"X 70\" WITH TAPE SPLIT 6\" X 21\" (1) \tNEEDLE SPINAL ANESTH 18G X 3%  (3) \tGOWN X-LARGE IMPERVIOUS REINFORCED (1) \tMAYO STAND COVER REINFORCED  (4) \tDR APE UTILITY WITH TAPE  (6) \tTOWEL ABSORBENT  15\" X 20\" (3) \tDRAPE % ECONOMY  53\" X 77\"  (1) \tYANKAUER OPEN TIP CLEAR W/0 CN  (1) \tCAUTERY TIP POLISHER (1) \tSUTURE BAG FLORAL  (1) \tGOWN SURG REINFORCED X-LARGE TOWEL & WRAP  (1) \tMERLING  SKIN PREP APPLICATOR  39ML (1) \tSHEET HAND 146\" X 104\" X 91\"  (1) \tTABLE COVER  REINFORCED 50\" X 90\"    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-2456-2014",
      "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"
    }
  ]
}