FDAClass IIJuly 8, 2020

Direct Supply Attendant Vital Signs Monitor recall

DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP)…

Why was Direct Supply Attendant Vital Signs Monitor recalled?

Failures were found in the temperature measurement function while in the predict mode.

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 Numbers: 456802000001~456802000180

Product
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP)…
Recalling firm
Mediana Co., Ltd.
Quantity
180 devices
Distribution
US Nationwide distribution.
Recall date
July 8, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls