| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00278-1 |
| Product Name/Description |
MobiCath Bi-Directional Guiding Sheath, Small Curve
(used to introduce cardiovascular catheters)
Product Number: D140010
Lot Number: W3338707
ARTG Number: 191013 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Greatbatch Medical has received reports of a pouch seal integrity issue with a specific lot of MobiCath Bi-Directional Guiding Sheath. One side of the pouch may not be sealed and as a result, may cause the sterile barrier of the pouch to be compromised. The use of a non-sterile product in surgery could potentially result in adverse health consequences, such as infection, which could lead to life threatening events and/or death. Greatbatch has received no reports of deaths, illnesses, injuries, or other adverse effects associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
JJM is advising users to immediately inspect the device(s) in their possession to determine if their facility has affected product, and then to quarantine the affected product prior to returning it to JJM for replacement.
This action has been closed-out on 21/03/2018. |
| Contact Information |
1800 252 194 (Option 4) - Johnson & Johnson Medical |