Home / Recalls / Medical Devices
Terumo Cardiovascular Systems Corporation recalls Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - Product Usage: intended for use
Recalled September 23, 2020 · FDA recall Z-2959-2020 · Terumo Cardiovascular Systems
Hazard
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. · FDA Class II
Units
100
Sold at
Worldwide distribution - US Nationwide distribution.
Description
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.
Product
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32, Catalog Number 5773 - 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.
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →