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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00589-1
Product Name/Description Polysorb Braided Absorbable Suture and EndoStitch Loading Unit with Polysorb Suture

Multiple Item and Lot Numbers

ARTG Numbers: 180104 and 181255
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 9/05/2017
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic has identified that there is the potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. The use of products with this condition may increase the potential for the suture to break. This packaging defect does not impact the sterility of the product. To date, Medtronic have not received any reports of serious injury associated with these issues.
Recall Action Recall
Recall Action Instructions Medtronic is advising users to quarantine and discontinue use of the affected item codes. Medtronic will arrange for collection and will issue credit for returned devices.

This action has been closed out on 20/09/2019

This action has been closed out on 20/09/2019
Contact Information 02 9857 9000 - Medtronic