{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "222021",
      "product_res_number": "Z-3181-2026",
      "event_date_initiated": "2026-07-23",
      "event_date_posted": "2026-09-16",
      "recall_status": "Open, Classified",
      "res_event_number": "99628",
      "product_code": "OFM",
      "product_description": "Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451;\r\nBlood Culture Kit 20/Cs, REF: 81834B;\r\nBlood Culture Collection Kit, REF: 81834C.\r\n\r\nAll containing BD ChloraPrep Clear - 1 mL Applicators",
      "code_info": "77451/20809160195069/343602(5/31/2027), 349005(10/31/2027), 374030(11/30/2027), 375434(12/31/2027), 377632(4/2/2028), 327194(8/31/2026), 375105(3/31/2028), 336074(3/21/2027);\n\n81834B/20809160403324/326214(7/31/2027);\n\n81834C/20809160466602/347551(8/12/2026), 372502(8/10/2026), 374615(10/21/2026), 376461(10/23/2026), 377088(11/6/2026), 373129(9/3/2026), 374033(9/3/2026)",
      "firm_fei_number": "1030451",
      "recalling_firm": "Medical Action Industries, Inc. 306",
      "address_1": "25 Heywood Rd",
      "city": "Arden",
      "state": "NC",
      "postal_code": "28704-9302",
      "additional_info_contact": "Marlene Jones\n470-280-4277",
      "reason_for_recall": "Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead to localized skin or soft tissue infection.",
      "root_cause_description": "Material/Component Contamination",
      "action": "On 7/23/2026, correction notices were emailed to customers who were asked to do the following:\n1) Identify, segregate, and quarantine all impacted product.\n2) Discontinue use of the BD ChloraPrep Clear - 1 mL Applicators\n3) Add warning labels to affected MAI kits to ensure all users are aware of the actions to discard the impacted component prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. \n4) Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\n5) Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.\n6) Complete and return Recall Response Form via email to GM-OMRA_RECALLS@owens-minor.com\n\nReport any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.",
      "product_quantity": "6,420",
      "distribution_pattern": "US Nationwide distribution in the states of OH, IN, NC.",
      "openfda": {
        "device_name": "Phlebotomy Blood Collection Kit",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2750",
        "device_class": "2",
        "registration_number": [
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