FDAClass IIJuly 28, 2021

Avsm3 SNF recall

AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation…

Why was Avsm3 SNF recalled?

In some cases the equipment fails to power up and/or key or button unresponsive or not working.

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?

Serial #(s) 460062000002 thru 460062000501 and 460062100033 thru 460062100150 UDI:(01)18800003460066

Product
AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation…
Recalling firm
Mediana Co., Ltd.
Quantity
618
Distribution
US Distribution to: Wisconsin only
Recall date
July 28, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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