BEUDAMED
    FDA Recall Open, Classified

    COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

    Recall: Z-0955-2023 · Initiated November 23, 2022

    Recall

    Recall Number
    Z-0955-2023
    Event Number
    91318
    Firm
    Covidien, LLC
    FEI Number
    3004962788
    Product Code
    NEY
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 23, 2022
    Posted
    January 12, 2023
    Address
    161 Cheshire Ln N, Ste 100, Minneapolis, MN, 55441-5433

    Description

    COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

    Reason

    The product is labeled with the incorrect expiration date.

    Action

    On about 11/23/2022, the single customer was notified with an "URGENT: MEDICAL DEVICE RECALL" letter via visit. The letter instructed the consignee to immediately identify, segregate, and quarantine affected products within your inventory, pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred, and to contact Medtronic to return affected product. Additionally. the consignee was instructed to complete and return the customer confirmation form even if you do not have any affected units. Return the form via email to [email protected] within 30 days of receipt. Contact us at 1-800-255-6774 to receive a return material authorization (RMA) and coordinate inventory replacement/credit. Return unopened affected units to: Medtronic Attention: [Insert RGA #], 4340 Swinnea Rd, Bldg A Memphis, TN 38118. If you have any questions regarding this communication, please contact your Medtronic Representative or Medtronic Customer Service at 800-962-9888.

    Distribution

    Foreign Distribution: Hong Kong

    Quantity

    21 units