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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01299-1
Product Name/Description	Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL 50mL CADD Medication Cassette Item Code: 21-7001-24 100mL CADD Medication Cassette Item Code: 21-7002-24 100mL CADD Medication Cassette, Yellow Item Code: 21-7100-24 Multiple Lot Numbers ARTG Number: 145297
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	17/10/2017
Responsible Entity	Smiths Medical Australasia Pty Ltd
Reason/Issue	Smiths Medical has become aware that certain Non-Flow-Stop CADD Medication Cassette Reservoirs may have been manufactured with an incorrect pressure plate. This product is designed without an arch, but the defective product has a plate with an arch. There is a risk that under delivery of medication may result from the tubing becoming partially or completely occluded when the cassette is attached to the pump. The clinician is not aware of the issue because the pump will continue to operate as if it is infusing medication without alarming for an occlusion.
Recall Action	Recall
Recall Action Instructions	Smiths Medical is advising users to quarantine remaining stock of the affected product for return for credit. It is recommended that users transition to an equivalent flow stop version of the CADD Medication cassettes. This action has been closed out on 17/07/2019
Contact Information	1800 654 949 - Smiths Medical Customer Service