Medical device manufacturer, Stryker Neurovascular, has issued a medical device safety alert concerning its Synchro2 Guidewires [UPN Code: M00326010, M00326110, M00326310, M00326320, M00326410, M00326420, M00326510 and M00326520; All Lots manufactured from 2 October 2017 to 1 June 2018].
The manufacturer has become aware that the product labels (pouch and carton) for Synchro2 products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.
According to the manufacturer, no adverse health consequences are anticipated. There is no risk to patients associated with previous use of affected devices. Hence, no product will be returned as a result of this action.
The affected users are requested to take the following actions:-
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 13 June 2018