Z-1933-2011

Rolko Adjustable (retractable) Strap and Handle, type TGN-R100GR; a component of a Lifting Pole, an accessory...

Name: Z-1933-2011 Rolko Adjustable (retractable) Strap and Handle, type TGN-R100GR; a component of a Lifting Pole, an accessory...
Creator: Arjo, Inc. dba ArjoHuntleigh
Published: 2011-02-24
License: https://open.fda.gov/license/

Arjo, Inc. / initiated 2011-02-24 / Terminated

FDA source

Arjo, Inc. dba ArjoHuntleigh began a recall of 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... on 2011-02-24. The reason FDA records is "Part of the housing of the strap retracting mechanism built into the handle may break while the patient is using the handle and strap". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1933-2011
Status: Terminated
Initiated: 2011-02-24
Posted: 2011-04-11
Terminated: 2011-06-14
Recalling firm: Arjo, Inc.
Product: 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
Product code: FNK Bed, Hydraulic, Adjustable Hospital
Reason for recall: Part of the housing of the strap retracting mechanism built into the handle may break while the patient is using the handle and strap.
FDA root cause: Other
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.
Quantity in commerce: 90 units
Distribution: Nationwide Distribution including California, Georgia, Hawaii, Michigan, South Carolina and Texas
Product codes and lots: 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 code FNK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)