FDA Medical Device Recalls (openFDA)
C.R. Bard, Inc.: Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
- Recall number
- Z-0760-2016
- Recalling firm
- C.R. Bard, Inc.
- Product
- Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
- Status
- Terminated
- Initiated
- 2015-11-10
- Posted
- 2016-02-05
- Terminated
- 2017-04-21
- Reason
- Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
- Root cause
- Use error
- Action
- Bard Medical Division sent a Safety Alert to each of the customers via FedEx with proof of delivery notice. All consignees have been instructed to carry the notification out to the user-level.
- Quantity
- 1,539
- Distribution
- Nationwide Distribution-DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI. IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
- Lot, serial or model codes
- All lots/serial numbers sold prior to August 2014.
- 510(k) numbers
- ["K071341","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