BEUDAMED
    FDA Enforcement Class II Terminated

    Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

    Recall: Z-2481-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2481-2018
    Event ID
    80289
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    February 20, 2018
    Classification Date
    July 18, 2018
    Termination Date
    November 4, 2019
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States

    Description

    Presource PBDS, Kit, Common. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

    Reason

    A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.

    Code Info

    Product Code SPK692448A (Lot Numbers 820352, 821938, 822522, 825665, 826987, 839110), Product Code SP1692448B (Lot Number 841315, 841803).

    Distribution

    US Nationwide Distribution in the states of California.

    Quantity

    8,928 kits total