BEUDAMED
    FDA Recall Terminated

    SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

    Recall: Z-1275-2021 · Initiated February 22, 2021

    Recall

    Recall Number
    Z-1275-2021
    Event Number
    87393
    FEI Number
    3003428886
    Product Code
    IWJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 22, 2021
    Posted
    March 18, 2021
    Terminated
    April 17, 2023
    Address
    25-27 Paul Street North, Sirtex Medical Limited Centrecourt Business Park Unit D4, North Ryde, New South Wales Australia

    Description

    SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

    Reason

    There is a potential presence of particulate matter in the D-Vial.

    Action

    Urgent Voluntary Medical Device Recall notification letters dated 2/22/21 were distributed to customers. Actions to be taken by the Customer/User: Sirtex is directing customers not to use the product from the recalled lots. Recalled product should be returned to Sirtex for credit. Please forward the notice in the event affected products were further distributed. Please fill out and return the attached Customer Acknowledgement and Receipt Form to [email protected]. Please complete this form whether or not you have affected product on hand. A mailing label will be provided via email for the return of the product once the form is received. Credit will be issued upon return of the product. Contact Sirtex Medical Customer Service at +1-888-474-7839, Monday through Friday, between the hours of 8 a.m. and 5 p.m., EST or via email [email protected] for assistance in returning affected product. Unaffected lots of Sirtex Legacy V-Vial product is available for replacement. Customers with questions regarding this recall can call Sirtex at +1-888-474-7839, Monday through Friday, between the hours of 8 a.m. and 5 p.m. EST and ask to speak with the Quality Assurance Department. Type of Action by the Company: Sirtex is working with our contract manufacturer to address the particulate issue. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    Distribution

    US Nationwide distribution.

    Quantity

    3310