medical Class II Updated 2020-09-23

Terumo Cardiovascular Systems Corporation recalls Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4

Recalled Product

Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand air detection and heart-lung systems to detect gross air bubbles in the line during extracorporeal procedures.


Hazard / Issue

Internal testing at the supplier, revealed that a crimped wire was placed into an air bubble detector (ABD) sensor connector backwards, preventing the crimped wire from locking into the mating wire connector. This intermittent connection may result in false air bubble alarms.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 00886799000052; Serial Numbers: 20019 20020
View official government recall

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