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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00344-1
Product Name/Description HOTLINE Fluid Warming Sets

Product Codes: L-70 and L-80

Multiple lot numbers affected

ARTG Number: 99436
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 18/03/2014
Responsible Entity Smiths Medical Australasia Pty Ltd
Reason/Issue Smiths Medical has become aware of an issue with a limited number of Warming Sets with the potential for leakage form the injection port at the top of the Warming Set. If fluid leaks at the injection port, the leak is readily detectable by the clinician who would stop using the Warming Set and obtain a replacement. This could present a minor delay in therapy while a replacement Warming Set is obtained.
Recall Action Recall
Recall Action Instructions Smiths Medical is requesting their customers to segregate all affected units. Upon confirmation of the location of affected units a service representative will arrange for the exchange of unused warming sets. This action has been closed-out on 31/08/2016.
Contact Information 02 9643 9200 - Smiths Medical Customer Service Department