FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: 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.
- Recall number
- Z-1395-2016
- Recalling firm
- C.R. Bard, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-03-04
- Posted
- not on file
- Terminated
- 2017-12-07
- Reason
- Complaints were received of restricted/inaccurate flow rate.
- Root cause
- Process control
- Action
- Bard Medical sent an Urgent Medical Product Recall letter dated March 4, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to not use any of the affected products and to return any unused product Bard Medical Division via the provided Customer Recall and Effectiveness Form. BMD will be providing a replacement for the returned product. If the product was further distributed, the consignee was instructed to identify their customers and notify them of the product recall.
- Quantity
- 21,412 units
- Distribution
- Worldwide Distribution - Domestic: US Nationwide; Foreign: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil Canada, Chile, China, Colombia, Croatia, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Oman Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, , South Korea, Kuwait, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, Turkey, United Arab Emirates, Ukraine, United Kingdom, Uruguay and Vietnam.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K142702"]
- PMA numbers
- not on file
- Product code
- DWJ
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28