| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00422-1 |
| Product Name/Description |
Papoose Infant Spine Immobilisers
Part Numbers Affected: PA-100, PAR-100 with replacement pads, PO-100 w/o P0 FRT, POR-100 w/o P0 FRT w/pad
Lot Numbers: before MX150727
ARTG Number: 135078 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Ossur has identified that the use of undeclared natural rubber latex in the leg (perineal) strap. Latex is a known allergen which can lead to allergic reactions in persons sensitive to latex. No injuries have been reported to date. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ossur has replaced the affected product with unaffected stock.
This action has been closed-out on 11/11/2016. |
| Contact Information |
1300 123 268 - Ossur Australia |