| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01087-1 |
| Product Name/Description |
Transradial Artery Access Kits
Product Codes: AA106111, AA15511-S, AA15611-S
Multiple serial numbers
ARTG Number: 135922 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has advised that this action is due to a foreseen risk that the introducer needles packaged within the kits can be partially or fully occluded. If an occluded needle is used on a patient, there is risk of delay in treatment and/or adverse event requiring medical intervention. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to quarantine any affected stock. Mayo Healthcare customer service will contact customers with affected stock to arrange return, dispatch of replacement stock, or issuance of a credit note. |
| Contact Information |
1300 360 226 - Mayo Healthcare Customer Service |