| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00496-1 |
| Product Name/Description |
Wilson Frame Tempur Pedic Pad Set
Product Codes:
5319G Radiolucent Wilson Frame
5321G Radiolucent Wilson Frame
5319-37 Replacement Wilson Frame Tempur Pedic Pads
Pad Manufacture Dates: 1 December 2016 to 20 March 2017
ARTG Number: 183116 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
An audit of the manufacturing process showed a variance in the construction of the model 5319-37 pads that may allow the patient to contact the underlying carbon fibre structure of the Wilson Frame and could lead to pressure injury. |
| Recall Action |
Recall |
| Recall Action Instructions |
LifeHealthcare is advising users to discontinue use of any Wilson Frame device with pad model 5319-37 and segregate the pads for return to LifeHealthcare. For replacement, users can choose either model 5319-36 Replacement Frame Gel pads or Tempur-Pedic pads.
This action has been closed-out on 27/03/2018. |
| Contact Information |
02 8114 1553 - LifeHealthcare |