{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 8
    }
  },
  "results": [
    {
      "cfres_id": "219243",
      "product_res_number": "Z-1910-2026",
      "event_date_initiated": "2026-03-11",
      "event_date_posted": "2026-04-22",
      "recall_status": "Open, Classified",
      "res_event_number": "98618",
      "product_code": "OWL",
      "product_description": "Arrow Echogenic Introducer Needle REF ASK-04001-BWK2\nUDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347\n\nThis device is intended for injection or aspiration of fluids. The needle protection device\ncovers the needle after use to help prevent needle sticks.",
      "code_info": "Product code: ASK-04001-BWK2\nUDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347\nBatch Number: 33F25J0347",
      "firm_fei_number": "3013162291",
      "recalling_firm": "ARROW INTERNATIONAL, LLC",
      "address_1": "3015 Carrington Mill Blvd",
      "city": "Morrisville",
      "state": "NC",
      "postal_code": "27560-5437",
      "reason_for_recall": "Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured",
      "root_cause_description": "Process control",
      "action": "On 03/18/2026, the firm sent via FedEx-2-day an \"URGENT MEDICAL DEVICE RECALL\" Letter informing customers that Ferndale Laboratories issued a Field Safety Notice (FSN) to inform users of multiple complaints reporting the butyrate tubing of the Mastisol Liquid Adhesive vial cracked during actuation. According to the Ferndale Laboratories FSN, one lot of MASTISOL Liquid Adhesive was exposed to a double sterilization cycle which may have contributed to the butyrate tubing becoming brittle and susceptible to cracking during actuation.\n\nMedical Facilities should:\n1. Immediately check inventory for product within the scope of this recall and cease use and distribution of affected product and immediately quarantine the affected product.\n2. For impacted product, mark the applicable checkbox on the Acknowledgement\nForm (Appendix 1) and contact Teleflex Customer Service utilizing one of the following\nmethods:\na. Fax, including  Attn: Customer Service , or email customer service using the point of\ncontact details outlined on Page 3 with a copy of Appendix 1\nOR\nb. Using the online FSN Portal, complete the acknowledgement form virtually using the\nfollowing link: https://fca.myteleflex.com/en/recall/000606\nNote: Option B is solely applicable to customers who received product direct from\nTeleflex.\n3. For impacted product, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and return the form to Teleflex at the contact details provided.\n4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product.\n\nDistributor should:\n1. Provide a copy of this recall notice to all customers who have received impacted product. Each customers is then required to complete the Acknowledgement Form and return it to Distributor.\n2. Request immediate check of inventory, cease use and distribution of, and quarantine, affected products and returned to Teleflex.\n\nFor questions-contact customer service at 1-866-396-2111 or email Recalls@telefle",
      "product_quantity": "85",
      "distribution_pattern": "U.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA, and VA.",
      "openfda": {
        "registration_number": [
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          "2245270",
          "3009211636",
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          "3015225571",
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          "1417592",
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          "9680794",
          "9616088",
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          "1423537",
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        ],
        "fei_number": [
          "1000512168",
          "1643817",
          "2245270",
          "1000138054",
          "3001236905",
          "3003094851",
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          "1000120555",
          "3009888344",
          "3003737899",
          "1625425",
          "2521402",
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        ],
        "device_name": "Peripheral Catheter Insertion Kit",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5200",
        "device_class": "2"
      }
    }
  ]
}