Z-2345-2016Class III

Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling...

Name: Z-2345-2016 Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling...
Creator: C.R. Bard, Inc.
Published: 2016-06-30
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-06-30 / Terminated

FDA source

C.R. Bard, Inc. began a recall of Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients on 2016-06-30. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2345-2016
Classification: Class III
Status: Terminated
Initiated: 2016-06-30
Posted: 2016-08-05
Terminated: 2017-06-06
Recalling firm: C.R. Bard Inc
Product: Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
Product code: DWJ System, Thermal Regulating
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.
FDA root cause: Other
Action: A Customer Communication Correction Letter was sent to customers on June 30, 2016. The letter requested that they examine inventory and remove the original IFU and substitute a copy of the IFU that was included with the Correction letter. The letter also requested a sub-recall, and included a reply form which was to be completed and returned. If you have any further questions please call (401) 825-8690.
Quantity in commerce: 64
Distribution: US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland
Product codes and lots: Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2345-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2345-2016	Class III	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-05

Product code DWJ

K142702Class IIArctic 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)