Recall Z-1947-2012— Arjo, Inc. dba ArjoHuntleigh
Class II · Terminated
Class II FDA medical device recall by Arjo, Inc. dba ArjoHuntleigh, initiated 2012-06-29, terminated 2018-03-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.. Reason: ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed..
- Recalling firm
- Arjo, Inc. dba ArjoHuntleigh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-29
- Terminated
- 2018-03-13
- Firm location
- Addison, IL, United States
Product description
Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.
Reason for recall
ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.