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
This recall has been terminated (originally issued April 11, 2011).
- Company
- Arjo, Inc. Dba Arjohuntleigh
- Recall Initiated
- February 24, 2011
- Posted
- April 11, 2011
- Terminated
- June 14, 2011
- Recall Number
- Z-1933-2011
- Quantity
- 90 units
- Firm Location
- Addison, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution including California, Georgia, Hawaii, Michigan, South Carolina and Texas
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.