BEUDAMED
    FDA Recall Terminated

    Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

    Recall: Z-1269-2020 · Initiated January 13, 2020

    Recall

    Recall Number
    Z-1269-2020
    Event Number
    84722
    Firm
    TELEFLEX MEDICAL INC
    FEI Number
    3005747797
    Product Code
    DWS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 13, 2020
    Posted
    January 27, 2020
    Terminated
    November 24, 2021
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440

    Reason

    There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

    Action

    The firm initiated the recall by letter on 01/13/2020. The actions to be taking be the consignees are as follows: Check inventory. If affected stock is found, discontinue use immediately and quarantine. Complete the 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 additional questions, contact the local sales representative or Customer Service at 1-866-396-2111.

    Distribution

    Worldwide

    Quantity

    1764 units