Terumo Ultrasonic Air Sensor Recalled for Intermittent Connection Defect
Terumo is recalling two Ultrasonic Air Sensors because a manufacturing defect may cause intermittent connections and false air bubble alarms during extracorporeal procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used in extracorporeal procedures where a defect could lead to false alarms, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling two units of the Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791. The affected units have UDI 00886799000052 and serial numbers 20019 and 20020. These sensors are 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.
Internal testing at the supplier revealed that a crimped wire was placed into the air bubble detector sensor connector backwards. This placement prevented the crimped wire from locking into the mating wire connector. As a result, the connection may be intermittent, which can lead to false air bubble alarms.
The recall covers two units that were distributed worldwide and nationwide in the US. Users of these specific serial numbers should contact Terumo Cardiovascular Systems Corporation for further instructions on how to proceed.
The recalled product
- 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.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 00886799000052
- Serial Numbers: 20019 20020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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