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 |