FDAClass IIOctober 3, 2012

Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD recall

Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal…

Why was Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD recalled?

Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo¿ Advanced Perfusion System 1 when there was no tubing in the flow sensor. Terumo CVS' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for Terumo System 1, the sensor operates correctly if the tubing is installed and it is highly unli

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?

Catalog number: 802018 and serial numbers: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, and 00823-00847.

Product
Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal…
Recalling firm
Terumo Cardiovascular Systems Corporation
Quantity
150 units
Distribution
Worldwide and US Nationwide Distribution
Recall date
October 3, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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