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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