The Recall Desk
ModerateFDA (Devices)·Z-0271-2018·Announced 2017-12-27

C.R. Bard Recalls Medivance ArcticGel Small Pad Kits Due to Peeling

C.R. Bard is recalling 24 Medivance ArcticGel Small Pad Kits because the hydrogel is peeling from the pads. The affected units were distributed to 10 US states.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any hospitalizations, injuries, or illnesses, and the defect (peeling hydrogel) is a functional issue rather than a high-risk pathogen or structural failure causing immediate severe harm, fitting the Moderate criteria for minor defects or low-risk issues.

Plain-English summary

C.R. Bard, Inc. is recalling 24 units of the Medivance ArcticGel Small Pad Kit. The recall is due to a defect where the hydrogel is peeling from the pads. The product is a thermal regulating system indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

The affected product is identified by Product Code 31705 and Lot # NGBS1063. The recall covers distribution to the states of Florida, Louisiana, Illinois, California, Missouri, Minnesota, Texas, Oklahoma, Tennessee, and New York.

The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected pads and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling pati
Manufacturer
C.R. Bard, Inc.
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product Code: 31705 Lot # NGBS1063

Distribution

Distributed in 10 states: