The Recall Desk
ModerateFDA (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.

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, 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 Universal
Manufacturer
Bard Medical Division
Category
Medical Device — Temperature Management
Hazard
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.

Related recalls

Same manufacturer · Bard Medical Division

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Same hazard · adhesion defect

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