Medical device manufacturer, Teleflex, has issued a medical device safety alert concerning its FiberOptix Intra-Aortic Balloon (IAB) Catheter Kit, Ultra 8 IAB, UltraFlex IAB. [Product Code: IAB-05830-LWS, IAB-05840-LWS, IAB-06830-U, IAB-06840-U, IAB-05830-U, IAB-05840-U, IAB-S730C, IAB-S840C; Lot number: multiple]
The manufacturer is voluntarily recalling the products referenced above because the products are not registered for distribution in this region. The local supplier clarified that the affected products mentioned above were not intended to be delivered to Hong Kong. No potential for patient harm has been identified because of this event.
Users should check their inventory for the affected products. They should not be used or distributed to others.
According to the local supplier, the products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 24 May 2021