FDAClass IISeptember 23, 2020

Terumo Advanced Perfusion System 1 Ultrasonic Air recall

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…

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: 00886799000045; Serial Numbers: 20230 20263 20265

Product
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…
Recalling firm
Terumo Cardiovascular Systems Corporation
Quantity
3
Distribution
Worldwide distribution - US Nationwide distribution.
Recall date
September 23, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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