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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00888-1
Product Name/Description	Of Spiggle & Thesis PTFE Ventilation Tubes - Fluoroplastic shepard button and Fluoroplastic collar button (Tympanostomy tubes used to ventilate the middle ear subsequent to otitis media) Fluorplastic shepard button, 1.15mm Ref.: 104115 Lot numbers: 201208220750, 201210120800, 201211090450, 201302261000, 201301091000 and 201304121000 Fluoroplastic collar button, 1.25mm Ref.: 104125 Lot number: 201301080700, 201302260700, A01210190500 and 201208130480 ARTG Number: 182921
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	20/08/2013
Responsible Entity	CoreMed Pty Ltd
Reason/Issue	The primary packaging of the affected products could potentially have damage to the seal or seam. The sterility of the articles concerned is not guaranteed. It may not be possible for the user to identify this fault with absolute certainty.
Recall Action	Recall
Recall Action Instructions	Customers are requested to quarantine the affected lots of product and organise with CoreMed for the return of any unused product.
Contact Information	02 9810 6947 - CoreMed