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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00124-1
Product Name/Description Terumo CVS CDI H/S Cuvette provided within the Medtronic Perfusion Tubing Pack

Model Numbers: M612501C, CB7W53R1, CB7P87R9 and M613301A

Lot Numbers: 210283502, 210370420, 210370463 and 210545011

ARTG Number: 232954
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 3/02/2016
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue It has been reported that when using an affected CDI H/S Cuvette in the CDI Blood Parameter Monitoring System 500, it may not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic is providing users with additional instructions to ensure the Cuvette is connected prior to surgery. If the cuvette cannot be properly seated, alternative methods of blood gas monitoring should be performed.
Contact Information 02 9857 9000 - Medtronic