Bard Inlay Optima Ureteral Stents InLay Optima Multi-length Ureteral Stent with NiCoreNitinol/Nitinol Guidewire, InLay Optima Multi-length Ureteral Stent with HydroGlide Guidewire, InLay Optima Multi-length Ureteral Stent without Guidewire 의 리콜

Recall

RC-2016-RN-01369-1

Class II

2016-10-18

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01369-1

The food and drug administration (fda) has requested manufacturers of multi-length ureteral stents to add a statement in the warnings/precautions section of product labelling, requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal. bard has completed an internal assessment and concluded that there is the potential for a moderate severity of harm to a patient should the medical professional fail to consider the formation of a knot if significant resistance is encountered during attempts at removal. bard is including additional warning/precaution for all of bard’s multi-length ureteral stents.

Bard is including additional warning/precaution for all of Bard’s multi-length ureteral stents: Formation of knots in multi-length ureteral stents may occur. This may result in injury to the ureter during removal and/or the need for additional surgical intervention. The presence of a knot should be considered if significant resistance is encounter during attempts at removal. Users are advised to follow the above warning/precaution for the stock they currently hold. Any stock purchased after November 15, 2016 is expected to have the above warning/precaution statement in the labelling. This action has been closed-out on 18/05/2017.