{
  "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; 1392 units (multiple units per lot)",
      "code_info": "Product code 900-998, 30 lots:  110102460  110112688  110123134  111010177  111020380  111040983  111051307  111061695  111071843  111082122  111092412  111092562  111102894  111123312  111123473  112020498  112030759  112041367  112072882  112083446  112093766  112114689  112125126  113026063  113036770  113078482  113109886  140111264  140311950  140412910",
      "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": "C-SECTION PACK -   (1) TABLE COVER REINFORCED 50\" X 90\" L/F  (3) TOWELS ABSORBENT 15\" X 20\" L/F  (1) BABY BLANKET  (1 0) GAUZE SPONGE 4\" X 4\" 16PLY XRD LIF  (1) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERV XL T/ WRAP LEVEL IV  (2) PAD OBSTETRICAL XL LIF  (1) LITE GLOVE LIF  (1) DRAPE SHEET 41\" X 69\" MEDIUM LIF  (2) SURGICAL BLADE #10 CARBON STEEL  (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF  (1) BAG GLASSINE  (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR  (1) CONTAINER 64oz WITH LID  (1) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF  (1) MAYO STAND COVER REINFORCED UF  (1) BAG SUTURE FLORAL  (15) LAP SPONGES PRE-WASH XRD LIF  (1) EAR ULCER SYRINGE 2oz UF  (1) CORD UMBILICAL CLAMP L/F  (1) WASH BASIN ?QT.  (1) CAUTERY TIP POLISHER LIF  (1) YANKAUER SUCTION TUBE W/0 VENT LIF  (1) C-SECTION DRAPE WITH POUCH 102\" X 121\" X 78\"  (1) FEEDING TUBE 8FR. 15\" LONG  (4) DRAPE UTILITY WITH TAPE UF  (1) TUBE SUCTION CONNECT. Y.\" X 12' UF  (2) GOWN SURG. SMS POLY-REINF BREATHABLE IMPERVIOUS XL LEVEL IV    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-2366-2014",
      "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"
    }
  ]
}