| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01527-1 |
| Product Name/Description |
Medtronic Clip Gun Scalp Clip System
GUN CG8900 RANEY CLIP KIT 1PK
Model Number: CG8900
Item Number: 00643169109100
Manufacture date: 26/05/2015 - 26/09/2017
KIT CG8091 CLIP GUN 10 PK
Model Number: CG8901
Item Number: 20643169109111
Manufacture date: 26/05/2015 - 02/06/2017
ARTG Number: 98997 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
19/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic Neurosurgery is initiating a recall of all affected model numbers and lot numbers of the Clip Gun Scalp Clip system.
Testing performed by Medtronic showed that the outer sterile pouch of the product did not meet standards for package integrity. Specifically, the testing demonstrated that the outer pouch could be compromised and possibly go undetected by the user which could potentially lead to patient infections. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic are advising hospitals to cease use of affected product. Medtronic will arrange for retrieval of affected items.
This action has been closed out on 07/11/2018 |
| Contact Information |
0438 427 673 - Medtronic Australasia |