FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
- Recall number
- Z-3042-2017
- Recalling firm
- C.R. Bard, Inc.
- Product
- Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
- Status
- Terminated
- Initiated
- 2017-03-31
- Posted
- 2017-08-16
- Terminated
- 2017-08-28
- Reason
- Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
- Root cause
- Unknown/Undetermined by firm
- Action
- Bard sent an Urgent Customer Notification letter dated March 31, 2017, to each of the U.S. consignees. The letter contained recommended actions and included an Acknowledgement Form to be returned. For further questions, please call (770) 784-6119.
- Quantity
- 3,450 units
- Distribution
- Worldwide Distribution - USA (nationwide) to the states of :AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WY., and to the countries of : Australia, Korea, Japan, Canada, Hong Kong, China, Singapore, & EMEA
- Lot, serial or model codes
- Product Codes 5000-00-00 & 5000-00-00E - All serial numbers
- 510(k) numbers
- ["K101092"]
- 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