BEUDAMED
    FDA Recall Terminated

    PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory

    Recall: Z-2127-2017 · Initiated April 21, 2017

    Recall

    Recall Number
    Z-2127-2017
    Event Number
    77081
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GCD
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    April 21, 2017
    Terminated
    January 27, 2020
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory

    Reason

    Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.

    Action

    Consignees were notified via Urgent Medical Device Recall letter on April 21, 2017. The letter identified the affected product, problem and actions to be taken. They were instructed to discontinue use and quarantine any products with the affected catalog numbers and lot numbers. They were to return the product, complete the enclosed Recall Acknowledgement Form and fax it to the Attn: Customer Service or email to [email protected]. A Recall Acknowledgment Form was enclosed to be completed and returned via fax even if they have no stock.

    Distribution

    Worldwide Distribution - U.S. Nationwide. Foreign consignees: Australia, Canada, China, Columbia, India, San Salvador, Singapore and South Korea.

    Quantity

    19,043 units in total