Recalls / —
—#142163
Product
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
- FDA product code
- DWJ — System, Thermal Regulating
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K071341, K101092
- Affected lot / code info
- All lots/serial numbers sold prior to August 2014.
Why it was recalled
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 (FDA determination)
Use error
Action the firm took
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.
Recalling firm
- Firm
- C.R. Bard, Inc.
- Address
- 8195 Industrial Blvd NE, Covington, Georgia 30014-1497
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2015-11-10
- Posted by FDA
- 2016-02-05
- Terminated
- 2017-04-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #142163. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.