Recall Z-0303-2017— Handicare USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Handicare USA, Inc., initiated 2014-04-15, terminated 2016-12-13. FDA's recall record names no specific 510(k) clearance for this event. Product: ReTurn 7500/7500 Aid, transfer. Reason: During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder..
- Recalling firm
- Handicare USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-15
- Terminated
- 2016-12-13
- Firm location
- Allentown, PA, United States
Product description
ReTurn 7500/7500 Aid, transfer
Reason for recall
During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder.
Data sourced from openFDA. This site is unofficial and independent of the FDA.