BEUDAMED
    FDA Recall Terminated

    Rolko Adjustable (retractable) Strap and Handle, type TGN-R100GR; a component of a Lifting Pole, an accessory to long term care hospital beds such as ArjoHuntleigh's Minuet 2 Community bed and Enterprise series hospital beds; Distributed by ArjoHuntleigh, a Branch of Arjo Limited Med AB, Wednesbury, United Kingdom Lifting poles are accessories intended to assist patients in positioning themselves on a hospital bed and the lifting pole is used in conjunction with a strap and handle. The strap and handle hangs from the lifting pole and the patient grasps the handle to pull upon the strap when repositioning themselves

    Recall: Z-1933-2011 · Initiated February 24, 2011

    Recall

    Recall Number
    Z-1933-2011
    Event Number
    57953
    Firm
    Arjo, Inc. dba ArjoHuntleigh
    FEI Number
    1419652
    Product Code
    FNK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 24, 2011
    Posted
    April 11, 2011
    Terminated
    June 14, 2011
    Address
    2349 W Lake St, Addison, IL, 60101-6183

    Description

    Rolko Adjustable (retractable) Strap and Handle, type TGN-R100GR; a component of a Lifting Pole, an accessory to long term care hospital beds such as ArjoHuntleigh's Minuet 2 Community bed and Enterprise series hospital beds; Distributed by ArjoHuntleigh, a Branch of Arjo Limited Med AB, Wednesbury, United Kingdom Lifting poles are accessories intended to assist patients in positioning themselves on a hospital bed and the lifting pole is used in conjunction with a strap and handle. The strap and handle hangs from the lifting pole and the patient grasps the handle to pull upon the strap when repositioning themselves

    Reason

    Part of the housing of the strap retracting mechanism built into the handle may break while the patient is using the handle and strap.

    Action

    ArjoHuntleigh sent an Urgent Field Safety Notice to all affected end users via UPS Ground on February 24, 2011. The notice informed the accounts of the potential for the strap retracting mechanism to break during use. The accounts were requested to check their inventory for the presence of adjustable straps and handles procured from ArjoHuntleigh, note if they have a red button on the retractor housing and the affected production dates as explained in the photographs in Figures 1 and 2 in the letter. Any straps and handles found as identified in Figures 1 and 2 should be removed from use and returned to ArjoHuntleigh. Any straps and handles with a yellow button design as shown in Figure 3 are not affected and can continue being used. The accounts were requested to complete and fax or mail the enclosed Customer Response Form to Arjo at 630-576-5012, indicating the number of strap and handles checked and how many were removed from use. Questions were directed to the ArjoHuntleigh Regulatory Department at 1-630-785-4885.

    Distribution

    Nationwide Distribution including California, Georgia, Hawaii, Michigan, South Carolina and Texas

    Quantity

    90 units