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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00670-1
Product Name/Description	Cardioxyl Sutures Product Numbers: : 73130AN, 73130T, 73P30A, 73P30AM, 73P30AN, 73P30BS, 73P30O, 73P30P, 73P30R, 73P30U, 73P30V, 73S30AE, 73S30AG, 73S30AT, 73S30AX, 73S30P and 73S30V Multiple batch numbers ARTG Number: 166050
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	23/06/2014
Responsible Entity	Reid Healthcare Pty Ltd
Reason/Issue	A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. The treatment substance which is used during the manufacture for easing the crimping process of the needles is only applied on the area where the thread is in contact with the needle ie, approximately one (1) cm from the end of the thread. The treated ends are clearly out of the implanted section of the thread.
Recall Action	Recall
Recall Action Instructions	Customers are advised to inspect their stock and quarantine all affected units. Reid Healthcare Pty Ltd will arrange for affected stock to be recovered and issued with replacement stock or a credit note.
Contact Information	02 6685 8789 - Reid Healthcare