| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01483-1 |
| Product Name/Description |
Balt Cristal Balloons
Product Number: CBV18x40/110
Batch Number: 00294780 - Expiry Date: 30/09/2022
ARTG Number: 164958
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Pyramed has identified a potential problem with the Y Connector detaching from the outer sheath of the device.
This may result in the balloon remaining partially inflated in the patient and this may require manual and/or surgical retrieval. |
| Recall Action |
Recall |
| Recall Action Instructions |
Pyramed is advising customers to isolate affected stock from inventory. Pyramed will arrange for collection and replacement of affected devices.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 651 882 - Pyramed customer support |