| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01019-1 |
| Product Name/Description |
Vygon Umbilical Catheters
Product Code: VY-270.03
Batch Numbers: 241116FR, 281116FR, 071216FR, 151216FR, 211216FR, 050117FR, 230217FR, 280217FR, 060117FR and 150217FR
ARTG Number: 141061 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Vygon has identified a non-systematic wrong marking on specific Vygon Umbilical Catheters. The first mark from the distal tip may be at 5.5cm instead of 4cm. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Technologies is requesting customers:
1.Ensure all relevant personnel at their facility are fully informed of this notice, including medical staff who use Vygon Umbilical Catheters;
2.Quarantine all affected stocks remaining at their premises; and
3.Complete and return the supplied Reply Fax Form to acknowledge receipt of the notice and quantity of affected stock.
This action has been closed out on the 24/09/2018 |
| Contact Information |
03 9371 0927 - Device Technologies |