Left Double Lumen Endobronchial Tube with Parker Flex-Tip 의 리콜

Recall

RC-2017-RN-00258-1

Class I

2017-03-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00258-1

An overseas complaint has been received from a physician where the product was not functioning as intended for single lung ventilation. the physician had an experience where after full intubation isolation was not successful when the physician turned the patient on his side to begin the procedure. the physician’s supposition was that the anatomy of the patient shifted in a way that occluded the bronchial lumen and prevented continued lung isolation. the physician replaced the endobronchial tube with another product and completed the procedure. to date, there has been no patient injury or harm.

Device Technologies Australia (DTA) is requesting customers to immediately cease the use of affected devices. Customers are further requested to inspect and quarantine affected stock prior to their return to DTA for a replacement.