Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK, Catalog Number 5785 - 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 is recalling three units of the Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor (Catalog Number 5785) due to a manufacturing defect. Internal testing by the supplier discovered that a crimped wire was incorrectly 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.
The affected units have serial numbers 20230, 20263, and 20265 and were distributed nationwide in the United States as well as worldwide. The product is intended for use with Terumo and Sarns brand perfusion systems. The recall notice does not specify a remedy for affected consumers.
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: 3 Lot/code info: UDI: 00886799000045; Serial Numbers: 20230 20263 20265
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.