Recall Z-0760-2016— C.R. Bard, Inc.
Class II · Terminated
Class II FDA medical device recall by C.R. Bard, Inc., initiated 2015-11-10, terminated 2017-04-21. It names 2 FDA 510(k) clearances: K101092, K071341. Product: Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.. 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..
- Recalling firm
- C.R. Bard, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-10
- Terminated
- 2017-04-21
- Firm location
- Covington, GA, United States
510(k) clearances named in this recall
2 on FDA's record- K101092 — ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
- K071341 — MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Arctic Sun 5000 and Arctic Sun 2000; Intended for monitoring and controlling patient temperatures.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.