{
  "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": 4
    }
  },
  "results": [
    {
      "cfres_id": "187932",
      "product_res_number": "Z-2068-2021",
      "event_date_initiated": "2021-05-19",
      "event_date_created": "2021-07-13",
      "recall_status": "Open, Classified",
      "res_event_number": "88120",
      "product_code": "N/A",
      "product_description": "Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.",
      "code_info": "Lot Numbers: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082",
      "firm_fei_number": "3015859709",
      "recalling_firm": "Arrow International Inc",
      "address_1": "2400 Bernville Rd",
      "city": "Reading",
      "state": "PA",
      "postal_code": "19605-9607",
      "additional_info_contact": "SAME\n610-378-0131",
      "reason_for_recall": "Marketed without a 510K",
      "root_cause_description": "No Marketing Application",
      "action": "Teleflex issued Urgent Medical Device Device Recall Letter (EIF-000470) on 19th May 2021 via FedEx 2-day mail. The letter states reason for recall, health risk and action to take:\nAction list number 1  Medical facilities\n1. We request that you check your inventory for product within the scope of this FSCA. Users should\ncease use and distribution of impacted product and quarantine immediately.\n2. If you do not have stock in scope of this FSCA mark the according checkbox on the\nAcknowledgement Form (Appendix 1) and return the form to the fax number or e-Mail address\nmentioned below.\n3. If you do have stock in scope of this FSCA, complete the Acknowledgement Form (Appendix 1\nand fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com . This will\nallow us to document the amount of product you have on hand for return. A customer service\nrepresentative will contact you with a Return Goods Authorization (RGA) Number and will provide\ninstructions for the return of products to Teleflex Medical.\nAction list number 2  Distributors\n1. Provide this field safety notice to all customers who have received product in scope of this FSCA.\nYour customer is then required to complete the acknowledgement form and return to you.\n2. We request that you check your inventory for product within the scope of this FSCA. Cease use\nlreleflex ARROW. 11-TERNATIONAL\nand distribution of impacted product and quarantine immediately. You may then return all product\nin scope.\n3. As a distributor, you are then required to confirm to Teleflex that you have completed the field\nactivity outlined above. Upon completion of your actions, please forward the completed\nAcknowledgement Form to Customer Service.\n4. If you have further distributed product outside of your country, please notify Teleflex by return email to the e-Mail address below\n\nCustomer Service:\nContact: Customer Service Telephone: 1-866-396-2111\nFAX: 1-855-419-8507 Email: Recalls@teleflex.com",
      "product_quantity": "48 units",
      "distribution_pattern": "US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.",
      "openfda": {}
    }
  ]
}