| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01258-1 |
| Product Name/Description |
AtriCure CryoICE cryo-ablation probe (CRYO2)
Lot Numbers: 26500 through to 53607
ARTG Number: 202110 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
This recall has been initiated due to a packaging defect that could potentially compromise the sterility of this device. Use of a non-sterile device could potentially cause permanent impairment or life-threatening injury. No injuries or deaths have been reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
Hospitals are requested immediately quarantine and return all affected stock to the Australian distributor, N Stenning & Co. This action has been closed-out on 04/08/2016. |
| Contact Information |
02 8594 9100 - N Stenning & Co. Customer Service |