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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00613-1
Product Name/Description	Multi Lumen and Pressure Injectable Central Venous Catheters Affected Lot Numbers: 71F14A0329, RF1082062, 71F13H0637, ZF3063390, 71F14C0868, ZF1124891, ZF3051182, 71F13K0810, 71F13J1589, 71F14C0173, ZF2052625, 71F13H0972, 71F13K1389, 71F13K1796, 71F13K0429, ZF2111681, 71F13H1291, 71F13L0166, 71F14A0120, 71F13K1808, 71F14A1404, 71F13K0325, 71F13L1212, 71F14B0386, ZF3052590, RF0127942, 71F13K1625, ZF2123457, 71F14B0029, RF1069981, RF0087867, ZF3040526, 71F14B0377 ARTG Number: 142543
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/06/2014
Responsible Entity	Mayo Healthcare Pty Ltd
Reason/Issue	There is a low level of occurrence (<0.02%) of the lumen exit and lumen size on the extension line being misprinted on central venous catheters (CVC). As an example, the distal lumen may be printed with the word 'medial 18 GA' instead of 'distal 16GA'. Misprinted labelling can cause user dissatisfaction with flow rates (ml/hr) in the case the lumen would be expected to perform as labelled for high volume gravity infused (the mismarked 16GA Lumen) since in reality this is an 18GA Lumen and gravity flow is approximately half (1/2) the expected flow rate in ml/hr for a 16GA lumen. This could result in a worst case scenario clinical intervention to use a pressure bag or pump to achieve adequate flow rates. The colour coding of all hubs is correct and corresponds to the Arrow system.
Recall Action	Recall for Product Correction
Recall Action Instructions	Mayo Healthcare Pty Ltd is advising their customers to be aware of the incorrect labelling.
Contact Information	1300 360 226 - Mayo Healthcare National Customer Service