Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1241-2019·Announced 2019-05-08

Bard Medical Recalls ArcticGel Pads Due to Adhesion Defects

Bard Medical Division is recalling specific lots of ArcticGel Pads because the hydrogel may not adhere properly to the pad.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, and the source text describes a potential issue with adhesion without reporting any injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Bard Medical Division is recalling specific lots of Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads. The recall involves 7,526 units distributed worldwide, including the United States, Argentina, Australia, Canada, Saudi Arabia, South Korea, Singapore, Thailand, and Chile.

The recall was initiated because the specific lots have potential issues that may result in insufficient adhesion of the hydrogel to the pad. These pads are used with the Arctic Sun Temperature Management System to provide a hydrogel layer that ensures contact between the patient's skin and the pad.

Healthcare facilities and consumers should stop using the affected ArcticGel Pads and contact Bard Medical Division for further instructions. The affected catalog numbers and lot numbers are listed in the official recall documentation.

The recalled product

Product: Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel…
Manufacturer: Bard Medical Division
Category: Medical Device — Temperature Management
Hazard: adhesion-defect
Affected units: 7,526

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 (20)

Catalog Number / lot number a) Intrepid ArcticGel Small Pad Kit
31705I / NGAXY602 b) Intrepid ArcticGel Medium Pad Kit
31707I / NGAXY603 c) Intrepid ArcticGel Large Pad Kit
31709I / NGAXY604 d) Intrepid ArcticGel Universal Pad
31700I / NGAXY601 e) ArcticGel Universal Pad
31700 / NGAW3898
NGAW3055
NGAZ3417
NGBP1302
NGBP2293
NGBQ1040 f) ArcticGel Universal Pad
4-pack
3170004 / NGAW2916
NGAW3893
NGAZ3735
NGBP2294
NGBQ1021 g) ArcticGel X-Small Pad
31703 / h) ArcticGel X-Small Pad
2-pack
3170302 / NGBP0392

Distribution

Distributed nationwide across the United States.

Same manufacturer · Bard Medical Division

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Same hazard · adhesion defect