Recall Z-0079-2015— Arjo, Inc. dba ArjoHuntleigh
Class II · Terminated
Class II FDA medical device recall by Arjo, Inc. dba ArjoHuntleigh, initiated 2013-01-21, terminated 2015-10-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals.. Reason: The upper portion of the hooks on the spreader bar are too flexible for holding the loops of the sling. The loop of the sling could potentially come out of the hooks if positioned in the upper portion of the hooks..
- Recalling firm
- Arjo, Inc. dba ArjoHuntleigh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-21
- Terminated
- 2015-10-27
- Firm location
- Addison, IL, United States
Product description
Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals.
Reason for recall
The upper portion of the hooks on the spreader bar are too flexible for holding the loops of the sling. The loop of the sling could potentially come out of the hooks if positioned in the upper portion of the hooks.
Data sourced from openFDA. This site is unofficial and independent of the FDA.