| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00768-1 |
| Product Name/Description |
ProcedurePak (surgical procedure packs)
Product Codes: 97032966-02, 97032967-01, 97034172-01, 97042192-00 & 97042192-01
Multiple batch numbers affected
ARTG Numbers: 215992, 215993, 216000 & 216001 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Molnlycke Health Care has identified that the sterile tubing supplied in certain ProcedurePak trays, may not have received an adequate sterilization dosage. This may lead to a compromise in sterility of one of the components in these trays. |
| Recall Action |
Recall |
| Recall Action Instructions |
Molnlycke is requesting their customers to identify and isolate all affected unused product at their facility. Molnlycke Health Care will arrange for collection and replacement of the product. |
| Contact Information |
02 8977 2114 - Molnlycke Health Care Regulatory and Quality Affairs |