Medical device manufacturer, Cook Medical, has issued a medical device safety alert concerning its Ultraxx Nephrostomy Balloon Set and the Ascend AQ Ureteral Dilation Balloon Catheter Set [Catalogue Number: UNBS-10-15-CS (Lot number: 5082013) and AUBS-6-4 (Lot number: 5083854)]. The affected products were distributed between 22 July 2014 and 6 August 2014.
The manufacturer has received reports of packages labeled as Ultraxx Nephrostomy Balloon Set actually containing the Ascend AQ Ureteral Dilation Balloon Catheter Set and vice versa.
According to the manufacturer, this event is not likely to lead to an adverse patient/user outcome and is obvious to the user. This nonconformity is detectable, making it less likely that an incorrect device would be used or misused during a procedure.
Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 February 2016