Recall Z-1395-2016— C.R. Bard, Inc.

Name: FDA recall Z-1395-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-04

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2016-03-04, terminated 2017-12-07. It names one FDA 510(k) clearance: K142702. Product: BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.. Reason: Complaints were received of restricted/inaccurate flow rate..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-04
Terminated: 2017-12-07
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K142702 — Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel PadMedivance, Inc.·cleared 2014-12-18

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

BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module.

Reason for recall

Complaints were received of restricted/inaccurate flow rate.

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