FDAClass IIJune 21, 2017

Monica Novii Wireless Patch System product Usage: Novii recall

Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of…

Why was Monica Novii Wireless Patch System product Usage: Novii recalled?

Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.

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?

See attached consignee list for affected device serial numbers.

Product
Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of…
Recalling firm
MONICA HEALTHCARE LTD
Quantity
4,110 (4,106 US; 4 OUS)
Distribution
The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees.
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls