Symmetry Surgical/Olsen – Single Use Electrocautery Forceps/Pencils/Cords 의 리콜

Recall

RC-2018-RN-00795-1

Class II

2018-06-19

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00795-1

Device technologies has been notified by the manufacturer, symmetry surgical, of a product complaint regarding a monopolar pencil and cord. the reporting site observed some anomalies in the packaging seal resulting from the package’s contents having migrated near or within the seal area. this condition increases the risk of the seal’s integrity being compromised. testing indicated that the defect is introduced during the packaging operation and will not result from shipping or normal handling conditions.

Device Technologies (DTA) is advising customers product is acceptable for use if it is visually confirmed that the package's contents do not interfere with the packaging seal and the seal is intact. Users are advised to either: - Inspect all affected product in accordance with the inspection instructions outlined in the Customer Letter. Product that does not meet acceptance criteria should be shipped back to DTA for credit. If users are uncertain if product is acceptable it is advised to return the item; OR - Ship stock held of the Olsen Single Use Electrocautery Forceps/Pencils/Cords back to DTA for credit.