BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1283-2023 · Initiated February 9, 2023

    Recall

    Recall Number
    Z-1283-2023
    Event Number
    91760
    Firm
    DeRoyal Industries Inc
    FEI Number
    1043214
    Product Code
    KDQ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 9, 2023
    Posted
    March 23, 2023
    Address
    200 Debusk Ln, Powell, TN, 37849-4703

    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.

    Action

    The firm issued an URGENT DEROYAL RECALL NOTICE its consignees by email and letter beginning on 02/09/2023. The notice explained the problem and risk, and requested the following actions be taken: Identify and quarantine any affected product found in inventory. If the product has been further distributed, please notify then of this recall. Firm is seeking product return. Questions about receiving credit for return merchandise, contact Jennifer Marsh at [email protected] or by phone 865-362-4203 or email us at [email protected]. If you have questions regarding this recall please contact us at 865-362-6465 or email us at [email protected].

    Distribution

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

    Quantity

    27,200 devices