Events

Recall of Device Recall Rolko Adjustable Strap and Handle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arjo, Inc. dba ArjoHuntleigh.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57953
  • Event Risk Class
    Class 2
  • Event Number
    Z-1933-2011
  • Event Initiated Date
    2011-02-24
  • Event Date Posted
    2011-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97822
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bed, hydraulic, adjustable hospital - Product Code FNK
  • 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.

Device

Device Recall Rolko Adjustable Strap and Handle
  • Model / Serial
    type TGN-R100GR strap and handle, produced between January 2007 and January 2009, which can be identified by the red button on the retractor housing and the traceability mark on the side of the housing. The traceability mark has the last two digits of the year in the inner circle with an arrow pointing to the month on the outer circle. Any strap and handle with a yellow button on the housing is not affected by the recall. The strap and handle was sold under part numbers CM-ACC09-1 and ENT-ACC01 by ArjoHuntleigh.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including California, Georgia, Hawaii, Michigan, South Carolina and Texas
  • Product 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
  • Manufacturer
    Arjo, Inc. dba ArjoHuntleigh

Manufacturer

Arjo, Inc. dba ArjoHuntleigh
  • Manufacturer Address
    Arjo, Inc. dba ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA