Recall Z-1933-2011 ยท FNK Bed, Hydraulic, Adjustable Hospital
Arjo, Inc. dba ArjoHuntleigh
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
| Date | Apr 11, 2011 (initiated Feb 24, 2011) |
| Status | Terminated |
| Reason | Part of the housing of the strap retracting mechanism built into the handle may break while the patient is using the handle and strap. |
| 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 r |
| Quantity | 90 units |
| Distribution | Nationwide Distribution including California, Georgia, Hawaii, Michigan, South Carolina and Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.