BEUDAMED
    FDA Enforcement Class II Ongoing

    DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B

    Recall: Z-1283-2023 · Reported March 29, 2023

    Enforcement

    Recall Number
    Z-1283-2023
    Event ID
    91760
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    DeRoyal Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2023
    Initiation Date
    February 9, 2023
    Classification Date
    March 23, 2023
    Address
    200 Debusk Ln, N/A, Powell, TN, 37849-4703, United States

    Description

    DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B

    Reason

    The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.

    Code Info

    GTIN 50749756377046, Lot 58447585 exp. 12/22/2027

    Distribution

    US Nationwide distribution in the states of Arizona, Texas, Virginia, Pennsylvania, California, Missouri, North Carolina, Illinois, Indiana, Ohio, Arkansas.

    Quantity

    27,200 devices