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

FDA device recall Z-1933-2011 · posted 2011-04-11 · Terminated

Recall details

Recalling firm

Arjo, Inc. dba ArjoHuntleigh

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.

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.

Root cause

Other

Status

Terminated

Product code

FNK

Quantity affected

90 units

Distribution

Nationwide Distribution including California, Georgia, Hawaii, Michigan, South Carolina and Texas

Date initiated

2011-02-24

Date posted

2011-04-11

Date terminated

2011-06-14

Location

Addison, IL