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Terminated

Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.

FDA Recall Z-0760-2016 · Posted 2016-02-05

Recalling FirmC.R. Bard, Inc.
Recall StatusTerminated
Product CodeDWJ
Date Initiated2015-11-10
Date Terminated2017-04-21
Product Quantity1,539

Reason for Recall

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.

Firm 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.

Root Cause

Use error

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101092ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000Medivance, Inc. · 2010-07-16K071341MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000Medivance, Inc. · 2007-08-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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