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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00184-1
Product Name/Description	Spiggle & Theis ENT sinus single-use suction tubes (used for paranasal sinus suction) Disposable suction tubes, 100mm length, sinus/nasal, 3.0mm dia, 45°angle, box of 50 (9fr) Product Code: REF 3010030 Lot Number: 014443 Disposable suction tubes, 100mm length, sinus/nasal, 4.0mm dia, 45°angle, box of 50 (12fr) Product Code: REF 3010040 Lot Number: 014645, 014832 ARTG Number: 205220
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	19/02/2016
Responsible Entity	CoreMed Pty Ltd
Reason/Issue	There is a chance that the connection between the tube and the tip is faulty. This can lead to the tip loosening during use. The resulting risk for the patient, is that the tip could be left behind in the treated area or could be inhaled, which may lead to a severe health impairment for the patient. To date we are not aware of such a case.
Recall Action	Recall
Recall Action Instructions	CoreMed is advising users to quarantine any remaining stocks of the affected product and return for replacement with unaffected stock. This action has been closed out on the 14/09/2018.
Contact Information	02 9810 6947 - CoreMed