Device Recall Rolko Adjustable Strap and Handle

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Nationwide Distribution including California, Georgia, Hawaii, Michigan, South Carolina and Texas
  • Description du dispositif
    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
  • 1 Event


  • Adresse du fabricant
    Arjo, Inc. dba ArjoHuntleigh, 2349 W Lake St, Addison IL 60101-6183
  • Société-mère du fabricant (2017)
  • Source