FDAClass IIJuly 23, 2014

Sarns Disposable Centrifugal Pump without X-Coating recall

Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.

Why was Sarns Disposable Centrifugal Pump without X-Coating recalled?

During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.

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?

Lot No. RA07, Lot No. QP02

Product
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Recalling firm
Terumo Cardiovascular Systems Corporation
Quantity
N/A
Distribution
Nationwide Distribution
Recall date
July 23, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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