{
  "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": "30 lots; 4396 units (multiple units per lot)",
      "code_info": "Product code 900-403,  30 lots:  112020525  112030955  112031372  112051682  112062486  112093590  112104107  112125170  112125315  113015449  113015695  113025960  113036485  113046957  113057479  113057817  113068169  113078573  113088813  113099289  113099571  131110076  131110409  131110586  131210970  140211667  140311937  140312382  140412836  140513246",
      "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 -  -  (7) TOWELS ABSORBENT 15\" X 20\"   (2) SCALPEL WEIGHTED SAFETY #1 0  (1) BLANKET BABY 30\" X 30\" POLY ABS IMP   (1) BOWL UTILITY QUART 32oz.  (1) TUBE FEEDING 8Fr. 15\" LONG  (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR  (1) BEANNIES BABY   (2) PAD OBSTRETICAL XLGE ST.  (1) SYRINGE 20cc W/0 NEEDLE LIL   (1) SYRINGE EAR/ULCER 2oz.  (1) BLANKET RECEIVING 100% COTION   (1) CLAMP UMBILICAL CORD ST.  (1) COVER TABLE REINFORCED 50\" X 90\"  (1) SYRINGE 10CC W/0 NEEDLE L/LOCK  (1) BOWL PLASTIC W/LID 80oz   (2) GOWN XL SMS IMPERVIOUS REINFORCED  (1) SHEET DRAPE 41\" X 58\" SMS   (1) DRAPE C SECTION W/POUCH 102\" X 121\" X 78\"  (1) YANKAUER SUCTION TUBE W/0 VENT   (1) WRAPPER 30\" X 30\"  (15) SPONGE LAP PREWASH 18\" X 18\" XRD   (1) TIME OUT BEACON NON WOVEN ST.  (1) TUBE SUCTION CO NN ECT~\" X 12'   (2) LIGHT SHIELD  (1) GOWN SURG REINF LARGE T/WRAP  (2) PK. STRIP STERI CLOSURE W' X 4\"  (1) POLISHER CAUTERY TIP   (1) DRESSING COMP OP 4\" X 14\"  (1) COVER MAYO STAND REINFORCED   (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER    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-2320-2014",
      "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"
    }
  ]
}