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U.S. Department of Health and Human Services

Class 2 Device Recall Rolko Adjustable Strap and Handle

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 Class 2 Recall
Rolko Adjustable Strap and Handle
see related information
Date Posted April 11, 2011
Recall Status1 Terminated on June 14, 2011
Recall Number Z-1933-2011
Recall Event ID 57953
Product Classification Bed, Hydraulic, Adjustable Hospital - Product Code FNK
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
Code Information 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.
Recalling Firm/
Manufacturer
Arjo, Inc. dba ArjoHuntleigh
2349 W Lake St
Addison, Illinois 60101-6183
Consumer Instructions Contact the recalling firm for information
Manufacturer 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 Determined
Cause 2
OTHER/UNDETERMINED: Pending
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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