| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00865-1 |
| Product Name/Description |
PHIL (Precipitating Hydrophobic Injectable Liquid) Non-Adhesive Liquid Embolic System
(intended for use in the embolisation of lesions in the peripheral and neurovasculature, including ateriovenous malformations and hypervascular tumours)
Product Codes: LEN10250, LEN10300, LEN10350
All Batch Numbers affected
Supplied under the Special Access Scheme (SAS) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
It was identified that the PHIL container (syringe) may elute unintended elements (metals) into PHIL device formulation. This elution may discolour the PHIL device, or may not change the appearance of the device. At this point no adverse events related to product deficiency or specific patient reactions were reported to the manufacturer. MicroVention has not currently identified possible risk to patients associated with previous uses of PHIL devices. Culpan Medical is in negotiations with the TGA regarding the need for any further actions. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to identify and quarantine all affected devices in their possession and return them to Culpan Medical. Recommended patient follow-up for doctors: continue to collect and report to the Therapeutic Goods Administration and the manufacturer any Adverse Events/Patient Reactions. This action has been closed-out on 10/05/2017. |
| Contact Information |
1800 820 193 - Culpan Medical |