BEUDAMED
    FDA Recall Terminated

    Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation.

    Recall: Z-2067-2011 · Initiated February 1, 2011

    Recall

    Recall Number
    Z-2067-2011
    Event Number
    57912
    Firm
    Therakos Inc
    FEI Number
    2523595
    Product Code
    LNR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 1, 2011
    Posted
    April 28, 2011
    Terminated
    March 13, 2014
    Address
    1001 Us Highway 202, Raritan, NJ, 08869

    Description

    Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation.

    Reason

    Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).

    Action

    Therakos notified all direct Therakos US and ex-US End Users and Distributor consignees via Federal Express courier with an Urgent Product Correction Notification, dated 2/1/2011. The letter identified the reason for recall along with the affected product. Customers were to immediately discontinue using and discard the identified affected lots of the product. Customers were to use alternative lots. In order to receive credit for the discarded product, customers were to complete the attached confirmation of receipt and destruction. If there were any questions, a question and answer section was provided but additional questions could be directed towards Therakos Customer Service Center at 1-800-828-6316, Option 2,1.

    Distribution

    Worldwide Distribution

    Quantity

    4,323 kits