Terumo Ultrasonic Air Sensor Recall Due to Intermittent Connection
Terumo is recalling 100 Ultrasonic Air Sensors because a manufacturing defect may cause false air bubble alarms during extracorporeal procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is an intermittent connection causing false alarms, which is a functional defect without reported injuries or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 100 units of the Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32 (Catalog Number 5773). The product is 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 (ABD) sensor connector backwards. This error prevents the crimped wire from locking into the mating wire connector, resulting in an intermittent connection. This defect may lead to false air bubble alarms.
The affected units were distributed worldwide and nationwide in the US. The recall covers specific serial numbers listed in the agency record. Users should stop using the affected sensors and contact the manufacturer for instructions on replacement or repair.
The recalled product
- 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
- Terumo Cardiovascular Systems Corporation
- Affected units
- 100
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 (1)
- UDI: 00886799000038
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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