| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00334-1 |
| Product Name/Description |
Sciatic Nerve Retractors
Part Numbers: 03.100.013, 03.100.014
Lot Numbers: T140390, T140675, T140677 ,T145819, T140566, T140673, T151369
ARTG Number: 296161
Johnson & Johnson Medical t/a DePuy Synthes - Wound retractor, intermediate/deep |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Johnson and Johnson has identified the potential for micropores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
Discoloration and moisture were identified within the packaging of the affected lots of Sciatic Nerve Retractors indicating that these pores may be present in the affected devices.
Even with diligent reprocessing/sterilisation of the retractor, subsequent patients may be at risk for infection and adverse tissue reaction due to retained fluids leaking out during use. |
| Recall Action |
Recall |
| Recall Action Instructions |
Johnson and Johnson are advising users to inspect stock and return any affected product as soon as possible.
This action has been closed out on 21/06/2019 |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical |