BEUDAMED
    FDA Enforcement Class II Terminated

    Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.

    Recall: Z-2881-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2881-2020
    Event ID
    86146
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Klarity Medical Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2020
    Initiation Date
    July 31, 2020
    Classification Date
    August 24, 2020
    Termination Date
    October 19, 2020
    Address
    600 Industrial Pkwy, N/A, Heath, OH, 43056-1528, United States

    Description

    Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.

    Reason

    Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.

    Code Info

    Lots R7504-30C: 70621Y and 81008X R7504-35BC: 70415V and 71220V R7504-35C: 81008W R7644-32.5BC: 71228S RC7221-25BC: 70502Y and 70621W RC7504-17.5C: 80411A and 80802W

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.

    Quantity

    111 units