| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00522-1 |
| Product Name/Description |
Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling with the keyhole clip fastening
ARTG Number: 146792 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Nortec Medical have advised that the keyhole clips on Pivot, Pivot Hygiene, Pivot Hammock and Tony Pringle clip style sling may break. There have been four recorded cases of failure of the keyhole clip that attaches a sling to a pivot framed hoist. These keyhole clips are the black plastic component which is attached to the sling by means of a webbing strap threaded through a slot. The affected clips have all broken at the slot.
If the clip on the sling were to fail under load (whilst a patient is being transferred), the patient will fall from the hoist. |
| Recall Action |
Recall |
| Recall Action Instructions |
Active Medical requests that all recalled sling/s must be removed from service and disposed of.
Users are requested to return a completed Urgent Medical Device Recall Notification form (provided with the Customer letter) and return it to Active Medical Supplies at recalls@activemedicalsupplies.com.au or fax to (07) 3899 8825 or post to Active Medical Supplies – Quality Assurance PO BOX 3392 TINGALPA QLD 4173.
This action has been closed out on 15/11/2018 |
| Contact Information |
07 3899 8887 - Active Medical |