Recall Z-1949-2012— 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: Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed.. 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
Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed.
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.