Recall Z-0079-2015 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc. dba ArjoHuntleigh
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.
| Date | Oct 17, 2014 (initiated Jan 21, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | URGENT FIELD CORRECTION RECALL letters dated January 21, 2013 were sent to all direct accounts (customers). The letters identified the potential safety related issue; included instructions on how to use the Medium Two Hooks Spreader Bars, and to complete and return the enclosed Customer Response form. Once the Customer Response form has been returned customers will be contacted by an ArjoHuntleigh service representative to make arrangements for the replacement of the existing spreader bars with spreader bars of a different design. Customers with any questions about this recall can contact A |
| Quantity | 363 spreader bars |
| Distribution | USA Distribution - AR, GA, MI, PA, and the District of Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.