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.
Check against the official notice below — it lists the full affected range.
Terumo Cardiovascular Systems Corporation has recalled two units of the Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor (Catalog Number 5791) with serial numbers 20019 and 20020. Internal testing discovered that a crimped wire was installed backwards in the air bubble detector sensor connector, which prevents the wire from properly locking into the mating connector. This defect creates an intermittent connection that may cause false air bubble alarms during use of the device.
The affected units were distributed worldwide, including across the United States. The recall record does not specify what action affected consumers should take regarding this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution. Quantity: 2 Lot/code info: UDI: 00886799000052; Serial Numbers: 20019 20020
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.