| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01009-1 |
| Product Name/Description |
Codman Neuro EDS 3 CSF External Drainage Systems
(indicated for draining cerebrospinal fluid (CSF) and other fluids when the insertion of a permanent internal shunt is not indicated)
EDS 3CSF External Drainage System with Ventricular Catheter
Part number: 82-1730
ARTG: 123236
EDS 3CSF External Drainage System (no Ventricular Catheter)
Part number: 82-1731
ARTG:122785
Lumbar Drainage Catheter Kit II with EDS 3System
Part number: 82-1738
All lot numbers affected
ARTG: 123489 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
The tubing within the system that drains CSF may leak or disconnect from the joints. Leakage and tube separations may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus). This may result in collapsed ventricles, subdural bleeding, or an inability to properly control elevated intracranial pressure. The tubing disconnection or leakage may also increase the risk of ventriculitis. If undetected or untreated each of these events may cause severe brain injury, which may lead to coma, stroke or death.
These systems are most often used on neurocritical care floors and these issues are likely to be detected immediately. |
| Recall Action |
Recall |
| Recall Action Instructions |
Johnson & Johnson Medical Pty Ltd (JJM) is issuing a two stage recall action to mitigate the risk of shortage for these devices in the market place.
STAGE 1 - INFORM: Inform customers regarding the product issues and what actions need to be undertaken in the interim.
STAGE 2 - RECALL: Customers should return affected product to JJM once they have sourced alternate product.
In the case where no substitute drainage system is immediately available, the EDS 3 System may continue to be used until an alternative product can be obtained. Manipulation of tubing should be minimised and extra vigilance (identified in the customer letter) is required for early detection of leakage and/or disconnection.
After the alternative products have been sourced by customers, affected products should be quarantined for returning it to JJM.
This action has been closed-out on 28/02/2018, |
| Contact Information |
1800 252 194 - JJM Customer Service |