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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00047-1
Product Name/Description	Single Limb Circuit for Pneupac Ventilators, with PEEP Valve Order code:100/905/301 Batch numbers: 121105, 130128, 130225, 130408, 130624, 131209, 140217, 140407, 140428 & 140616 Order code:100/905/302 Batch numbers: 120229, 120326, 120402, 120507, 120716, 120820, 130318, 130520, 130819, 131007, 131125, 131216, 140526, 140707 & 140714 ARTG number: 109570
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	19/01/2015
Responsible Entity	Smiths Medical Australasia Pty Ltd
Reason/Issue	Certain Single Limb Circuits were labelled as “MR Conditional” but contained PEEP valves that should have been labelled as “MR Unsafe”. If the affected products are used in an MR environment, there is a potential for the PEEP valve to become dislodged during the MRI procedure. The effect of a reduction of PEEP pressure could be a reduction in oxygen saturation of the blood which would be detectable by clinical observation of signs and symptoms and through oximetry. Also there is the potential for the affected products to create artifacts in the MRI scan; however, these artifacts would be highly detectable by the clinician reading the MRI.
Recall Action	Recall
Recall Action Instructions	Facilities that use the Single Limb Circuit in the MRI suite are requested to quarantine the affected devices. A Smiths Medical representative will arrange for the exchange of unused affected product. This action has been closed-out on 08/08/2016.
Contact Information	02 9899 7172 - Smiths Medical Customer Service