Type of Product |
Medical Device |
TGA Recall Reference |
RC-2012-RN-01173-1 |
Product Name/Description |
MOBICATH Bi-Directional Guiding Sheath, small curve (used to introduce cardiovascular catheters)
Small Curve
Product Number: D140010
All lots
ARTG Number: 191013 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
21/11/2012 |
Responsible Entity |
|
Reason/Issue |
The manufacturer observed some anomalies of the inner lumen of these products during visual inspection utilising a new inspection tool. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string like liner material (from scratches or damage on the inner wall of sheath lumen). |
Recall Action |
Recall |
Recall Action Instructions |
Quarantine and return affected devices to Johnson & Johnson Medical. |
Contact Information |
1800 252 194 Option 1 - Johnson & Johnson Medical Customer Service |