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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	Johnson & Johnson Medical Pty Ltd
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