BEUDAMED
    FDA Recall Open, Classified

    FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    Recall: Z-2598-2021 · Initiated August 11, 2021

    Recall

    Recall Number
    Z-2598-2021
    Event Number
    88548
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    FSA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 11, 2021
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520

    Description

    FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    Reason

    Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.

    Action

    Hillrom issued URGENT Medical Device Correction letter dated August 11, 2021 by third party vendor via UPS mail/track the delivery to consignees. Letter states reason for recall, health risk and action to take: Hillrom is initiating this Medical Device Correction to all customers and will be correcting devices with an updated to the leveller. Actions being taken by Customer: Please share this Medical Device Correction with all potential users in your organization. Please ensure inspection of the device prior to use as stated in the device Instruction for Use (IFU). Complete the attached response form, acknowledging receipt, indicate the number of devices and return to [email protected] within one month

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DE, IL, ME, MI, MO, MS, NJ, OH, PA, VA, WA and the countries of Argentina, Australia, Austria, Bolivia, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates.

    Quantity

    129 units