BEUDAMED
    FDA Recall Terminated

    PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the body through a PVC tube via a continuous, low pressure vacuum pump (PureWick DryDoc) or to a hospital wall vacuum. There is never a reversal of flow direction or static state of fluid between the device and the patient. Also, the dry natural rubber component is double wrapped with 75D polyester and it is not stretched in its application to expose bare rubber to a user. The Wick does not enter the vagina (Figure 1).

    Recall: Z-1485-2017 · Initiated February 24, 2016

    Recall

    Recall Number
    Z-1485-2017
    Event Number
    76571
    Firm
    Purewick Corporation
    FEI Number
    3012224959
    Product Code
    NNW
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 24, 2016
    Posted
    March 6, 2017
    Terminated
    May 9, 2017
    Address
    2030 Gillespie Way, Ste 109, El Cajon, CA, 92020-0910

    Description

    PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the body through a PVC tube via a continuous, low pressure vacuum pump (PureWick DryDoc) or to a hospital wall vacuum. There is never a reversal of flow direction or static state of fluid between the device and the patient. Also, the dry natural rubber component is double wrapped with 75D polyester and it is not stretched in its application to expose bare rubber to a user. The Wick does not enter the vagina (Figure 1).

    Reason

    PureWick is recalling external catheter for women Wicks because the labeling did not contain the phrase "This product contains dry natural rubber" and/or erroneously included the phrase "Latex-free." The white gauze component of the PureWick contains dry natural rubber.

    Action

    A Urgent Medical Device recall letter dated March 2, 2017 will be sent to customers to inform them that PureWick Corporation is recalling specific lots of PureWick external catheter for women Wicks, Item #625. Customers are informed that PureWick is recalling PureWick Wicks because labeling on product shipped prior to February 22, 2017 either did not contain the phrase This product contains dry natural rubber and/or erroneously included the phrase Latex-free. The white gauze component of the PureWick Wick contains dry natural rubber. PureWick Corporation has received zero complaints or reports of adverse events related to the error in labeling. Customers are informed of the risk to health and the actions to be taken. Customers are instructed to complete the enclosed PureWick Field Correction form and fax to PureWick Corporation at (619) 660-5459 or email to [email protected]. Customers with questions or would like assistance completing the PureWick Field Correction Form are instructed to call PureWick toll-free at (844) 584-0734 Monday Friday from 8:00 a.m. to 4:30 p.m., Pacific Time.

    Distribution

    US: Nationwide Distribution

    Quantity

    176,863 units