Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Percuflex Plus Ureteral Stent [UPN: M0061752530; Batch: 25713850].
The manufacturer has received notification from the National Inspection Program of non-conformances identified for renal core strength, removal force, and elongation. The non-conformances identified were a result of an administrative error. According to the manufacturer, no adverse health consequences or patient risk are expected to occur.
Affected users should identify, segregate and return the affected product.
According to the local supplier, the affected product is not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 Aug 2021