BEUDAMED
    FDA Recall Terminated

    E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology

    Recall: Z-1480-2013 · Initiated August 2, 2012

    Recall

    Recall Number
    Z-1480-2013
    Event Number
    64927
    Firm
    Kreg Medical Inc.
    FEI Number
    3005179379
    Product Code
    OSI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 2, 2012
    Posted
    June 5, 2013
    Terminated
    March 2, 2018
    Address
    2240 W Walnut St, Chicago, IL, 60612-2218

    Description

    E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology

    Reason

    An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position.

    Action

    Kreg Medical sent an Urgent Voluntary Medical Device Recall letter dated May 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Kreg Medical started replacing potentially defective beds with refurbished beds in August 2012. All of the potentiall defective beds were refurbished by November 20, 2012. Customers were requested to send back the Medical Device Recall Return Response to confirm receipt of the notification letter. For questions regarding this recall call 312-275-7070.

    Distribution

    Nationwide Distribution including IL and IN.

    Quantity

    59 beds