Recall Z-3042-2017— C.R. Bard, Inc.

Name: FDA recall Z-3042-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-31

Class II · Ongoing

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2017-03-31, terminated 2017-08-28. It names one FDA 510(k) clearance: K101092. Product: Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US. 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..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2017-03-31
Terminated: 2017-08-28
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K101092 — ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000Medivance, Inc.·cleared 2010-07-16

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 Temperature Management System, 100-120 V North America and 100-120 V US

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.