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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00878-1
Product Name/Description Mahurkar Acute Lumen Catheters, labelled with Non-DEHP Symbol. (Closed loop, haemaodialysis catheter)

Multiple Product codes

ARTG Numbers: 180135 and 178965
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 3/09/2012
Responsible Entity Covidien Pty Ltd
Reason/Issue There is a labelling discrepancy pertaining to certain configurations of the Mahurkar Acute Dual Lumen Catheter. During a review of the product labelling, it was discovered that the devices are labelled as not containing the phthalate Bis (2-ethylhexyl) phthalate (DEHP), when in fact they contain small amounts of DEHP.
Recall Action Recall for Product Correction
Recall Action Instructions Update labelling to include phthalate Bis (2-ethylhexyl) phthalate(DEHP) symbol.
Contact Information 02 9429 3100 - Travis Stephenson