Recall Z-2345-2016— C.R. Bard, Inc.

Name: FDA recall Z-2345-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-30

Class III · Terminated

Class III FDA medical device recall by C.R. Bard, Inc., initiated 2016-06-30, terminated 2017-06-06. It names one FDA 510(k) clearance: K142702. Product: Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.. Reason: An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected..

Recalling firm: C.R. Bard, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-06-30
Terminated: 2017-06-06
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 Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.

Reason for recall

An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.

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