| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00165-1 |
| Product Name/Description |
FIAB Ultrasound Transmission and IPL Transparent Gel
Batch number: FG260901 (5L clear), FG240903 (5L blue) and FG180701 (260mL clear)
Order codes: WS1G008 (260mL clear), WS1G0084 (5L clear) and WS1G0064 (5L blue)
ARTG Number: 161851 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
TGA Laboratory testing has identified that these batches may be contaminated with bacteria (Burkholderia cepecia). |
| Recall Action |
Recall |
| Recall Action Instructions |
Westcoast Surgical Supplies have requested their customers to inspect their stock and quarantine any affected units. Recovery and replacement/credit note will be organised for all affected units. |
| Contact Information |
08 9455 6676 - Westcoast Surgical and Medical Supplies |