BEUDAMED
    FDA Recall Terminated

    Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to an infant/neonate patient. These gases may be delivered by nasal prongs using the CareFusion Infant Flow system and the single limb circuit, or through bypassing upper airways, for example through the use of an endotracheal tube with the dual limb configuration.

    Recall: Z-1912-2019 · Initiated May 10, 2019

    Recall

    Recall Number
    Z-1912-2019
    Event Number
    82994
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    BZE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 10, 2019
    Posted
    July 15, 2019
    Terminated
    April 22, 2024
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF 870-07KIT b) REF 870-09KIT Product Usage: The Neonatal ConchaSmart breathing circuits are intended to deliver humidified breathing gases for administration to an infant/neonate patient. These gases may be delivered by nasal prongs using the CareFusion Infant Flow system and the single limb circuit, or through bypassing upper airways, for example through the use of an endotracheal tube with the dual limb configuration.

    Reason

    Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.

    Action

    The firm initiated the recall by email on May 10, 2019. The recall notice requested the return of the product. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. For questions contact Customer Service at 1-866-396-2111.

    Distribution

    US Nationwide Distribution in the states of AL, TX

    Quantity

    20 units