| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01042-1 |
| Product Name/Description |
Basin Liner within Molnlycke ProcedurePak (surgical procedure packs)
ARTG entries: 133559, 133562, 133564, 133565 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
During standard quality checking of components for use within Molnycke Health Care ProcedurePak it has been found that some units of the basin liners provided in the pack have small holes in them which could be undetectable in normal use. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Molnlycke Health Care is requesting their customers to remove the affected basin liner from the pack once the pack is opened for surgery. A sterile bowl should be used in place of the liner. |
| Contact Information |
1800 005 232 - Molnlycke Health Care |