FDAClass IIJuly 26, 2023

NovaPlus Infant Heel Warmer recall

NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010

Why was NovaPlus Infant Heel Warmer recalled?

Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI/DI (Case) 50885380057586, (Box) 20885380057585, (EA) 10885380057588, Lot Number V2S056

Product
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Recalling firm
Cardinal Health 200, LLC
Quantity
44,500 units
Distribution
US Nationwide distribution.
Recall date
July 26, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls