Recall Z-0271-2018— C.R. Bard, Inc.

Name: FDA recall Z-0271-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-16

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2017-10-16, terminated 2020-06-24. It names one FDA 510(k) clearance: K142702. Product: Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.¿. Reason: Hydrogel peeling from the pads..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-16
Terminated: 2020-06-24
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

Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.¿

Reason for recall

Hydrogel peeling from the pads.

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