Terumo Advanced Perfusion System 1 Ultrasonic Air recall
Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32, Catalog Number 5791 - Product Usage: intended for use with Terumo and Sarns brand…
Why was Terumo Advanced Perfusion System 1 Ultrasonic Air recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00886799000052; Serial Numbers: 20019 20020
- 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…
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Quantity
- 2
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Recall date
- September 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)