Medcomp Hemo-Cath LT and Hemo-Cath ST Hemodialysis catheters 의 리콜

Recall

RC-2015-RN-00693-1

Class I

2015-08-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00693-1

Medcomp has become aware of the potential for holes developing in the silicone extension tubing of the hemo-cath catheters. during insertion, users may clamp over the guidewire which may cause initial damage to the tubing and over time this could develop into a leak.An initial crack in the tubing on the inside may propagate over time and eventually travel through the full thickness of the tubing developing into a hole that leaks.These holes may leak when the catheter is being accessed or pressurised during a treatment. the timeframe of when the holes are discovered is immediately post insertion or after several months of usage or longer.In the event a hole develops in the tubing, there is a potential for blood loss, air emboli, infection, delays in treatment and/or surgical procedure to remove and replace the device prior to continuing a dialysis treatment.

Users are reminded that during the insertion of the device not to clamp over the guidewire as this may initiate damage to the tubing that could progress into a leak over time. As an ongoing corrective measure, a new stylet tag with this instruction will also be included in future product. No actual product is being recalled from the Market. This action has been closed-out on 12/08/2016.