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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