The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1395-2016·Announced 2016-04-20

C.R. Bard Recalls ArcticGel Pads Due to Flow Rate Issues

C.R. Bard is recalling 21,412 ArcticGel Pads used with the Arctic Sun Temperature Management System because of complaints regarding restricted or inaccurate flow rates.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (restricted/inaccurate flow rate) in a medical device used for patient temperature management, which poses a risk of harm even though specific injuries are not detailed in the source text.

Plain-English summary

C.R. Bard, Inc. is recalling 21,412 units of BARD ArcticGel Pads. These pads are intended for use exclusively with the Arctic Sun Temperature Management System Control Module, which is used for monitoring and controlling patient temperature. The recall covers all lots with specific catalog numbers (31700, 3170004, 31703, 3170302, 31705, 3170502, 31707, 3170702, 31709, and 3170902) that are within their current expiration dates.

The recall was initiated after complaints were received regarding restricted or inaccurate flow rates in the product. The affected units were distributed worldwide, including across the United States and numerous foreign countries such as Argentina, Australia, Austria, and the United Kingdom.

Healthcare facilities and consumers should stop using the affected ArcticGel Pads immediately. Users should contact C.R. Bard, Inc. for instructions on how to return the product or obtain a replacement.

The recalled product

Product
BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Temperature Management
Hazard
Affected units
21,412

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 (10)

  • All lots with Catalog numbers: 31700 (Universal Pad)
  • 3170004 (Universal Pad 4 pk)
  • 31703 (XSmall pad kit)
  • 3170302 (XSmall pad kit 2 pk)
  • 31705 (Small pad kit)
  • 3170502 (Small pad kit 2 pk)
  • 31707 (Medium pad kit)
  • 3170702 (Medium pad kit 2 pk)
  • 31709 (Large pad kit) and 3170902 (Large pad kit 2 pk)
  • that are within their current expiration dates.

Distribution

Distributed nationwide across the United States.

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